INSIGHTS PDF Free Download
1 / 19/19
100%
DISCLAIMER:Sidvim LifeSciences Private Ltd has taken due care and caution in developing this document.
Since the data in this document is compilation of information available in the public domain, its adequacy,
accuracy or completeness cannot be guaranteed. This document is for information only and Sidvim is not
responsible for losses that may or may not arise due to any decisions made on the basis of the same. No part of
the document shall constitute or be represented as a legal opinion of any kind or nature. No warranties or
guarantees, expressed or implied, are included in or intended by the document, except that it has been prepared
in accordance with the current generally accepted practices and standards consistent with the level of care and
skill exercised under similar circumstances by professional consultants or firms that perform the same or
similar services.
INSIGHTS
UPCOMING EVENTS
REGULATORY
FINANCE AND M&A
HEALTHCARE TECHNOLOGIES
DRUG APPROVALS
BIOLOGICS
CDMO/CRO
OTHERS
CONTENT
02
03
06
08
10
13
16
19
FRIDAY, 19 JULY 2024
PAGE 2
27TH SEPTEMBER, 2024 | CROWNE PLAZA, GURUGRAM
REGISTER NOW
Key Discussion Points
Creating error-free supply chain model: What it takes?
India’s medical tourism potential: it is the healing world
Driving the change: Next Gen CEOs transforming healthcare paradigm
Promoting Inclusivity in healthcare: Addressing Disparities and Access Barriers
From bench to bedside: Elevating Patient-Centric Care through Personalization,
Technology integration and innovation
CEOs panel discussion on strengthening public and private partnership for
sustainable healthcare solutions
UPCOMING
EVENTS
REGULATORY HEALTHCARE
FINANCE DRUG
APPROVALS
PAGE 3
ABBVIE’S HUMIRA LOSS OF EXCLUSIVITY A MISSED OPPORTUNITY FOR
COMPETITORS: GLOBALDATA
AbbVie‘s market leadership, driven by its flagship
disease-modifying antirheumatic drug Humira
(adalimumab), faced a significant test with the 2023 loss
of patent protection. Despite an anticipated competitive
surge, rivals have struggled to capitalise. AbbVie’s
strategic shift to Skyrizi (risankizumab) and Rinvoq
(upadacitinib) has solidified its position, underscoring a
missed opportunity for competitors in the immunology
market, says GlobalData.
AbbVie has maintained a strong position within the
immunology space for the past few years, largely due to
the success of its anti-tumor necrosis factor (TNF)
inhibitor, Humira. On December 31, 2002, the drug
received its first FDA approval to treat rheumatoid
arthritis in adult patients and saw $246 million in US
sales the following year on market.
In subsequent years, the strength of this asset has only grown with its expansion into additional diseases, with
annual US sales peaking in 2022 at $18.6 billion. However, with the loss of patent protection in the US at the
start of 2023, and the ensuing flood of adalimumab biosimilars to the market, AbbVie has faced a decline in
sales of Humira, indicated by a 39.9 per cent decrease in the first-quarter year-over-year US Humira revenue in
2024, which has been attributed to biosimilar competition.
Adeleke Badejo, Managing Analyst – Immunology at GlobalData, states, “This scenario once viewed as an
opening for competitors to knock AbbVie off its throne, now is seen as a lost opportunity. AbbVie utilised a
two-prong approach towards Humira, with the anti-interleukin (IL)-23 inhibitor biologic, Skyrizi
(risankizumab), and the Janus kinase inhibitor (JAKi), Rinvoq (upadacitinib).”
This was a unique strategy, as other competitors typically focus on positioning a signal asset as the next
generation offering. Upadacitinib as the second candidate is of note due to the general safety concerns associated
with the JAKi drug class at the time. With these two therapies, AbbVie has followed Humira’s gameplay of
targeting multiple common disease, such as inflammatory bowel disease, and psoriasis,” adds Badejo.
Expresspharma,16TH July,2024
UPCOMING
EVENTS
REGULATORY HEALTHCARE
FINANCE DRUG
APPROVALS
PAGE 4
Throughout AbbVie’s retooling process, its stiffest challenge has been within the evolving IL-23 drug class,
as the only JAKi of note in recent years has been BMS’ Sotyktu (deucravacitinib), and though Sotyktu has
been approved to treat psoriasis, trial failures in ulcerative colitis (UC) and Crohn’s disease (CD) have
reduced the therapy’s potential as a blockbuster or challenger. However, with the development of IL-23,
AbbVie has been directly challenged by competitor assets, Lilly’s Omvoh (mirikizumab) and Janssen’s
Tremfya (guselkumab).
Tremfya was the first of the three to reach the market with plaque psoriasis approval in the US in July 2017
(Nov 2017 EU). This was followed by Skyrizi in April 2019, and recently, Omvoh which was approved to
treat UC in May (EU) and October 2023 (US).
Badejo continues, “Once seen as a three-horse race, the IL-23 market is now led by AbbVie’s Skyrizi,
exemplified by its four approved indications compared only to two for Tremfya. The failure of Omvoh to
show superiority over the older, anti-IL-23/12 therapy, Janssen’s Stelara, has only bolstered AbbVie
standing.”
In addition to navigating past loss of Humira exclusivity and maintaining its place within the market, recent
acquisitions indicate AbbVie’s intention to only strengthen its position within immunology.
On June 13, 2024, AbbVie announced a licence agreement with FutureGen to develop FG-M701, a TNF-like
cytokine 1A (TL1A). TL1A has garnered significant attention after the substantial acquisition price for these
assets seen last year, $10.3 billion by Merck, $7.1 billion by Roche, and $1.5 billion by Sanofi. The upfront
cost of $150 million by AbbVie could be seen as measured in comparison.
AbbVie also announced on June 27, 2024 the acquisition of Celsius Therapeutics, and notably CEL383, an
anti-triggering receptor expressed on myeloid cells 1 (TREM1) antibody that has completed a Phase 1
clinical study for the treatment of IBD, for $250 million.
“The recent reports, such as Boehringer Ingelheim plans on reducing the safesforce due to poor sales of its
adalimumab biosimilar, and the sale of Coherus BioSciences’ Humira biosimilar for only $40 million,
indicate that the adalimumab market may not be as promising as anticipated,” Badejo concludes.
UPCOMING
EVENTS
REGULATORY HEALTHCARE
FINANCE DRUG
APPROVALS
The report pointed out that countries worldwide categorise nutraceuticals similarly to the FSSAI, including
vitamins, minerals, and pre- and probiotics, citing RK Sanghavi, chairman of the Nutraceutical Committee of
the Indian Drug Manufacturers’ Association (IDMA). He stressed that FSSAI’s alignment with global practices
ensures the safety of these products.
Committee to deliberate nutraceutical authority
Earlier this year, a high-level committee was established to review the existing guidelines and propose a new
regulatory framework. This committee includes senior officials from the ministries of health and family
welfare, food processing industries, the Department of Pharmaceuticals, FSSAI, the Drug Controller General of
India, the Indian Council of Medical Research, and the director general of health services. They are actively
deliberating on measures to regulate the nutraceutical industry.
PAGE 5
PHARMA GROUPS CRITICISE PLAN TO SHIFT NUTRACEUTICALS UNDER
DRUG AUTHORITY
business-standard, Jul 17 2024
The government’s initiative to transfer the oversight of nutraceuticals from the Food Safety and Standards
Authority of India (FSSAI) to the drug regulatory authority is facing significant opposition from
pharmaceutical lobby groups and industry experts, according to The Economic Times. Critics argue that the
proposal should be suspended until it undergoes a thorough discussion.
The business-daily, citing industry experts, claimed that India’s nutraceutical regulations are in line with
Codex Alimentarius, a global standard set by the World Health Organization (WHO) to ensure consumer
safety. The FSSAI regulations, they note, are also consistent with international practices, similar to those in the
US, UK, Australia, China, Japan, and the EU.
UPCOMING
EVENTS
REGULATORY HEALTHCARE
FINANCE DRUG
APPROVALS
Hypoparathyroidism is a rare condition defined by PTH deficiency that results in low calcium and elevated
levels of phosphorus in the blood.
Clinical manifestations of this condition impact tissues and organ systems, specifically kidneys and bone.
Eneboparatide is a subcutaneous parathyroid hormone receptor 1 agonist for the treatment of
hypoparathyroidism.
Its therapeutic goals are to regulate serum calcium levels, manage hypoparathyroidism symptoms, reduce
urine calcium excretion and potentially prevent kidney function decline and chronic kidney disease.
Its short plasma half-life may help normalise bone turnover and maintain bone health.
Another candidate in Amolyt’s pipeline is AZP-3813, a peptide growth hormone receptor antagonist being
developed as a potential add-on to somatostatin analogues for the treatment of acromegaly, a condition
associated with abnormally high secretion of growth hormone.
AstraZeneca’s rare disease portfolio generated $7.76bn in global sales in 2023, as reported in the company’s
fourth-quarter financial reports.
"AstraZeneca completes Amolyt Pharma acquisition" was originally created and published by
Pharmaceutical Technology, a GlobalData owned brand.
PAGE 6
ASTRAZENECA COMPLETES AMOLYT PHARMA ACQUISITION
GlobalData, Jul 16, 2024
AstraZeneca has closed the acquisition of Amolyt Pharma, a
company specialising in treatments for rare endocrine diseases.
The deal between the parties was announced in March 2024.
AstraZeneca made a $1.05bn payment for all outstanding
shares of Amolyt Pharma, free of cash and debt.
The transaction includes an upfront payment of $800m and an
additional $250m contingent upon reaching a particular
regulatory milestone.
The strategic move strengthens AstraZeneca's late-stage
pipeline within its Alexion rare disease division and adds the
investigational therapeutic peptide eneboparatide (AZP-3601)
to its bone metabolism portfolio.
Eneboparatide is in Phase III development for
hypoparathyroidism and binds to the parathyroid hormone
(PTH) receptor with high affinity.
UPCOMING
EVENTS
REGULATORY HEALTHCARE
FINANCE DRUG
APPROVALS
New Delhi, July 16 (IANS) The Indian pharma and healthcare sector witnessed significant
activity in the April-June quarter (Q2) this year with 55 deals totalling $4.1 billion, marking an
8 times increase in values and a 10 per cent rise in volumes over the previous quarter, a report
showed on Tuesday.The average deal size surged from $9.7 million in Q1 2024 to $74 million
this quarter, driven by 11 high-value deals worth $3.4 billion, compared to just one high-value
deal worth $150 million in Q1 2024, according to the report by Grant Thornton Bharat.
“As India strives towards 'Viksit Bharat,' we anticipate a substantial rise in the health budget to
approximately 3 per cent of GDP in the upcoming Union Budget 2024,” said Bhanu Prakash
Kalmath SJ, Partner and Healthcare Services Industry Leader.
Compared to Q2 2023, deal values increased by 57 per cent despite a notable $2 billion deal in
the previous year executed by Temasek Holdings to acquire a 41 per cent stake in Manipal
Health Enterprises.
Volumes witnessed a similar trend with 49 per cent growth, reaching 55 deals this quarter, up
from 37 deals in Q2 2023, according to the report.
Domestic consolidations led in deal volumes, while outbound deals dominated in values,
contributing 74 per cent to the M&A space.
Private equity (PE) activity in Q2 2024 saw 37 deals valued at $2.7 billion, a 3 per cent
increase from Q1 2024.
The largest PE deal was KKR Asian Fund IV's investment in Healthium MedTech, valued at
$843 million, accounting for 31 per cent of the quarter's PE values.
PAGE 7
INDIAN PHARMA, HEALTHCARE SECTOR SAW 55 DEALS WORTH $4.1BILLION
IN Q2 2024
investing.com, 16th July
WILMINGTON, Del., July 16, 2024 /PRNewswire/ -- SPI Pharma, Inc. a global leader in biopharmaceutical excipient and adjuvant
systems, and Inimmune, Corp., a pioneering biotechnology company specializing in the discovery and development of innate immune
modulators, announce an agreement in principle to create a strategic collaboration to develop and commercialize advanced adjuvant
systems for vaccine development. This collaboration leverages Inimmune's world-class expertise in adjuvant formulation and
immunotherapeutics and SPI Pharma's extensive manufacturing and global commercial capabilities.
Adjuvant systems are critical components of vaccines that enhance immune response and efficacy. The partnership will aim to provide
reliable supply and open access to advanced adjuvant systems, addressing significant unmet needs in vaccine development and
accelerating the availability of these technologies to healthcare providers and patients globally.
"Inimmune's dedication to advancing immunological research coupled with SPI Pharma's robust commercial infrastructure creates a
powerful synergy," said John McInerney, Vice President of Commercial for SPI Pharma. "Together, we are poised to deliver innovative
solutions that can potentially transform vaccine efficacy and patient outcomes worldwide."
"We are excited to collaborate with SPI Pharma to bring our vaccine adjuvant technologies to market," said Alan
Joslyn, Ph.D., CEO of Inimmune. "This partnership underscores our shared commitment to improving public
health through innovation."
About Inimmune: Inimmune Corp. (Missoula, MT) is a privately held clinical stage biotechnology company focused on the discovery
and development of innovative immunotherapeutics, vaccine adjuvants and vaccines. Inimmune is harnessing the human immune
system via novel innate immune modulators to create safe and effective treatments for allergy, infectious disease, autoimmunity and
cancer. Their laboratories and offices are housed in the Montana Technology Enterprise Center (MonTEC) in Missoula. For more
information on Inimmune's research and development of novel vaccine adjuvants and delivery systems, please visit
www.inimmune.com.
About SPI Pharma: SPI Pharma, headquartered in Wilmington, Delaware, USA, provides innovative products and technical solutions to
global pharmaceutical customers. Product lines include Vaccine Adjuvant Systems, Drug Delivery Systems, Antacid Actives, Taste
Masking and Excipients. SPI Pharma specializes in drug development services, having participated in over 60 commercially launched
and marketed drugs globally. With its sites in the United States, France, and India, the company solves the most challenging
formulation problems –– efficiently, cost-effectively, and with a focus on service.
PAGE 8
SPI PHARMA, INC. AND INIMMUNE, CORP. PARTNER TO DEVELOP AND
COMMERCIALIZE INNOVATIVE VACCINE ADJUVANT SYSTEMS
SPI Pharma, Inc., 16 Jul, 2024,
UPCOMING
EVENTS
REGULATORY HEALTHCARE
FINANCE DRUG
APPROVALS
PAGE 9
HUMA RAISES $80M TO TURN TEXT INTO HEALTHCARE APPS WITH GEN AI
venturebeat, 16th July 2024
The power of AI is touching all sectors, including the highly regulated space of healthcare. Today, London-
based Huma, a health-tech company focusing on advancing digital-first care delivery and research, announced
the launch of an AI-powered cloud platform that provides startups with the ability to prototype, launch and
scale regulated digital health apps, including those powered with AI smarts, targeting different use cases.
Enterprises using the new Huma Cloud Platform get a variety of tools, but the biggest highlight is a generative
AI-powered builder experience that can turn text prompts into ready-to-use applications within minutes.
Huma says the offering is already being used by a handful of startups and large pharmaceutical companies. The
company also announced it has closed $80 million in series D funding to further expand the reach of the
platform and add more capabilities to it.
“We are here to accelerate the adoption of digital and AI across care and research, and we do that by making
the building of digital health solutions for care and research easy. We like to think of Huma Cloud Platform
like Shopify but for digital health instead of e-commerce. We believe when digital and AI are scaled, they
become affordable for both the poor and the rich. They remain consistent and will help us transition medicine
from being reactive to proactive,” Dan Vahdat, founder and CEO of Huma, said in a statement.
UPCOMING
EVENTS
REGULATORY HEALTHCARE
FINANCE DRUG
APPROVALS
Topamax Capsules, 15 mg and 25 mg market achieved annual sales of approximately USD 21.9 million, the
company said citing IQVIATM sales data for the 12-month period ended May 2024.
The company said its current portfolio consists of 198 products authorised for distribution in the US marketplace
and 50 ANDAs (Abbreviated New Drug Applications) pending approval with the USFDA.
The company said it continues to identify and explore external development partnerships to supplement and
accelerate the growth of its existing pipeline and portfolio.
PAGE 10
GLENMARK PHARMA RECEIVES USFDA APPROVAL FOR SEIZURE
TREATMENT DRUG
business-standard, 17th July
Glenmark Pharmaceuticals Ltd on Wednesday said it has received final approval from the US health regulator
for its generic Topiramate capsules used to treat certain types of seizure.
The approval by the US Food & Drug Administration (USFDA) is for Topiramate capsules of strengths 15 mg
and 25 mg, Glenmark Pharmaceuticals said in a statement.
Glenmark's Topiramate capsules USP, 15 mg and 25 mg have been determined by the FDA to be bioequivalent
and therapeutically equivalent to Topamax capsules, 15 mg and 25 mg of Janssen Pharmaceuticals, Inc., and will
be distributed in the US by Glenmark Pharmaceuticals Inc., USA, it added.
UPCOMING
EVENTS
REGULATORY HEALTHCARE
FINANCE DRUG
APPROVALS
PAGE 11
MEDICUS PHARMA LEVERAGES AI IN PHASE 2 TRIAL, TARGETS FDA
APPROVAL FOR SKIN CANCER THERAPY
proactiveinvestors, 15 July 2024
Medicus Pharma (TSX-V:MDCX) has announced the submission of an updated clinical trial protocol to the
United States Food and Drug Administration (FDA).
This protocol is for a Phase 2 trial of a new treatment for basal cell carcinoma (BCC), a common type of
skin cancer. The treatment involves using micro-needle arrays containing doxorubicin (D-MNA), developed
by its subsidiary, Skinject, Inc.
The submission to the FDA includes updates to the clinical trial design, as well as information on the
chemistry, manufacturing, and control processes for the drug. It also contains data on the drug's stability and
sterility. These updates address comments from the FDA received in March 2024.
"This Phase 2 clinical protocol, in its final form, is a comprehensive design, well positioned to get the nod
from the FDA to commence randomizing participants hopefully before the end of this quarter," said Dr
Raza Bokhari, chairman and CEO of Medicus.
Medicus provided safety data from a previous Phase 1 study completed in March 2021. This data supports
the use of two doses of the drug, 100 micrograms (μg) and 200 micrograms (μg). The company also
updated its investigator brochure with safety information from earlier clinical trials.
The new Phase 2 trial will be a randomized, double-blinded, placebo-controlled study. This means that
participants will be randomly assigned to different treatment groups, and neither the participants nor the
researchers will know who is receiving the actual treatment or a placebo. The trial will include up to 60
people with nodular BCC, a specific type of skin cancer.
Participants will be divided into three groups: one receiving a placebo, one receiving a low dose of 100
micrograms of D-MNA, and one receiving a high dose of 200 micrograms of D-MNA. The high dose is the
same as the maximum dose used in the previous Phase 1 study, which found the treatment to be safe and
well-tolerated.
The results from the initial trial showed that the drug was well-tolerated at all dose levels, with no serious
side effects or significant health issues. Six participants experienced complete responses, meaning their
BCC disappeared completely by the end of the study.
The updated Phase 2 protocol also includes new technologies to improve the accuracy of the trial. One
clinical site will use artificial intelligence (AI) and confocal microscopy, a technique for detailed imaging,
as supplementary methods to assess the treatment's effectiveness. This addition aims to eliminate the need
for invasive diagnostic procedures.
Bokhari said: "We are very excited to incorporate artificial intelligence-powered software and confocal
microscopy as supplemental endpoints in one of the clinical sites to improve the assessment accuracy of the
clinical program and hopefully also eliminate any invasive intervention even at the diagnostic stage, making
our treatment regimen completely non-invasive from start to finish."
UPCOMING
EVENTS
REGULATORY HEALTHCARE
FINANCE DRUG
APPROVALS
PAGE 12
A meeting with industry experts took place in April subsequent discussions have been limited to government
officials, leaving industry stakeholders in the dark about ongoing developments, the report said, citing a source.
Experts have warned that removing even just vitamins and minerals from FSSAI’s purview could shrink the
nutraceutical market by 70 per cent. Additionally, the government is considering implementing price controls to
make these products more affordable for consumers.
Growing consumption of nutraceuticals
Nutraceuticals, which include supplements, functional foods, and beverages with added health benefits, are a
rapidly growing sector. Industry data predicts that the Indian market for these products will expand from $4
billion in 2020 to $18 billion by 2025.
Earlier this year, a survey by LocalCircles in February revealed that 70 per cent of respondents regularly
consume various nutraceuticals, such as vitamins and dietary supplements. About 71 per cent of Indian
households use these products routinely, yet nearly 69 per cent do so without consulting a doctor. The survey
also showed that 68 per cent of consumers purchase nutraceuticals from local stores, while 25 per cent turn to
online platforms. Only 31 per cent of these purchases are based on medical prescriptions, indicating a potential
lack of awareness about the risks of unsupervised consumption.
Moreover, the survey highlighted a strong public demand for government intervention in regulating the
nutraceutical market. Approximately 78 per cent of respondents supported capping the prices of essential
nutraceuticals, such as Vitamin A and C, due to affordability concerns.
UPCOMING
EVENTS
REGULATORY HEALTHCARE
FINANCE DRUG
APPROVALS
PAGE 13
SERUM INSTITUTE OF INDIA'S NEW 'HIGH EFFICACY' MALARIA VACCINE
ROLLS OUT IN AFRICA
TheEconomicTimes, 15 July 2024
A new "high efficacy" malaria vaccine co-developed by the Serum Institute of India (SII) and the University
of Oxford was officially rolled out on Monday when Cote d'Ivoire in West Africa became the first country to
begin administering R21/Matrix-M. The vaccine, which was granted World Health Organisation (WHO)
approval last year, is said to have undergone a rigorous regulatory process and clinical assessment and was
found to be highly effective and affordable.
As a low-dose vaccine, it can be manufactured at speed and scale which is seen as critical to Stemming the
spread of the mosquito-borne disease. "Reducing the malaria burden is finally within sight. Today's start of the
R21/Matrix-M vaccine roll-out marks a monumental milestone after years of incredible work with our partners
at Oxford and Novavax," said SII CEO Adar Poonawalla.
"At Serum, we believe that it is every person's right to have access to affordable and essential disease
prevention. That's why we have committed to producing 100 million doses of R21, which will protect millions
of lives and alleviate the burden of this deadly disease for future generations,” he said.
In anticipation of the roll-out, SII said it has manufactured 25 million doses of the vaccine and is committed to
scaling up to 100 million doses annually. In keeping with its aim of delivering vaccines at scale and low cost,
the Pune-headquartered company said it is offering the vaccine at less than USD 4 per dose.
"The roll-out of the R21/Matrix-M malaria vaccine marks the start of a new era in malaria control interventions
with the high efficacy vaccine now accessible at a modest price and very large scale to many countries in
greatest need. We hope that this vaccine very soon can be provided to all African countries who wish to use it,"
said Professor Adrian Hill, Director of the Jenner at Oxford University.
HEALTHCARE DRUG APPROVAL CDMO &CRO
BIOLOGICS OTHERS
PAGE 14
R21/Matrix-M was co-developed by the university and SII leveraging Novavax's Matrix-M adjuvant technology.
In December 2023, WHO granted it prequalification status after trials demonstrated that the vaccine was well
tolerated, with a good safety profile, with injection site pain and fever as the most frequent adverse events.
Although the number of malaria-related deaths has fallen from 3,222 in 2017 to 1,316 in 2020 in Cote d'Ivoire,
the deadly disease still kills four people a day, mostly small children, and "remains the leading cause of medical
consultations", according to the country's Ministry of health.
A total of 656,600 doses have been received, which will initially vaccinate 250,000 children aged between 0 and
23 months across 16 regions of Cote d'Ivoire. The R21/Matrix-M vaccine has also been authorised by Ghana,
Nigeria, Burkina Faso and the Central African Republic.
R21 is the second malaria vaccine available in Sub-Saharan Africa following RTS,S and wide implementation of
the malaria vaccines, in conjunction with existing prevention methods like bed nets, is expected to save tens of
thousands of young lives each year. In total, 15 African countries are expected to introduce malaria vaccines
with Gavi support in 2024, and countries plan to reach around 6.6 million children with the malaria vaccine in
2024 and 2025.
Dr Sania Nishtar, Chief Executive Officer of Gavi, the Vaccine Alliance, said: "Africa has borne the brunt of
malaria for far too long, and Cote d'Ivoire has suffered more than most. With two safe and effective vaccines
now available alongside other interventions, we can finally turn the tide against this killer disease.”
John Jacobs, President and Chief Executive Officer, Novavax, added: "The introduction of the R21/Matrix-M
malaria vaccine in Cote d'Ivoire marks a breakthrough in the fight to protect vulnerable children against a
leading cause of death across the region while reinforcing our mission to create innovative vaccines that improve
public health."
VERTEX SUIT SEEKS US NOD TO PAY FOR FERTILITY TREATMENTS
MSN, 16th July, 2024
Vertex Pharmaceuticals Inc. sued the US government for permission to pay
for fertility treatment for people who get a gene therapy made by the company
that can interfere with reproduction.
Casgevy, the company’s $2.2 million therapy for sickle cell disease and beta
thalassemia, requires patients to undergo high-dose chemotherapy to remove
flawed cells from the bone marrow so they can be replaced with modified
versions. Chemo can render patients infertile, and many patients seek
additional expensive treatments to protect their reproductive ability. Vertex
wants to pay for those procedures for patients on government health programs,
but says the US views that as an illegal inducement to use the gene therapy.
Risk of infertility is among the top reasons that patients hesitate to get some
new gene therapies that have the potential to cure disease with a single
treatment, Bloomberg News has reported. Finding ways to circumvent side
effects without adding to already high costs is
HEALTHCARE DRUG APPROVAL CDMO &CRO
BIOLOGICS OTHERS
PAGE 15
has reported. Finding ways to circumvent side effects without adding to already high costs is a significant battle
for companies that make the treatments.
The suit, filed Monday in federal court, names the US Department of Health and Human Services, HHS
Secretary Xavier Becerra, agency Inspector General Christi Grimm and her office as defendants. Vertex said in
the suit that it’s trying to overturn the inspector general’s “erroneous legal positions” that are holding back
patients from getting the therapy.
In recent years, the US government has cracked down on potential violations of the anti-kickback statute, which
bars pharmaceutical companies from funding programs that induce patients to take drugs that are federally
reimbursed. A spokesperson for the HHS Office of Inspector General declined to comment.
Success in court for Vertex could benefit rival Bluebird Bio Inc., which also offers a gene therapy for sickle
cell disease that carries the risk of infertility.
Vertex shares rose 0.8% Monday at 3:53 p.m. Bluebird’s increased as much as 11%.
Fertility treatments can cost tens of thousands of dollars and often are not covered by insurance. About half of
sickle cell patients get their health coverage through Medicaid, the government program for low-income
people.
The case is Vertex v. US Department of Health and Human Services, 24-cv-02046, US District Court, District
of Columbia (Washington).
HEALTHCARE DRUG APPROVAL CDMO &CRO
BIOLOGICS OTHERS
German contract development and manufacturing organisation (CDMO) Corden Pharma announced a €900m
($980m) investment to expand its diabetes drug manufacturing capabilities, as shortages persist around the
world.
The company declared that the investment would be used over the next three years to expand its peptide
manufacturing capabilities at sites in Colorado, US, and Europe. The facilities will have a particular focus on
GLP-1 peptide manufacturing, as the demand increases. In a 16 July press release, the company spoke of
multiple long-term contracts worth more than €3bn with potential benefits.
Last year, the company signed a major deal with Eli Lilly to manufacture the active pharmaceutical ingredient
for its leading obesity drug Mounjaro (tirzepatide), as per a Reuters report. In January 2023, the company also
shared the signing of a $1bn multi-year agreement to manufacture a large volume peptide with an undisclosed
company.
The latest investment will be used to construct a greenfield site for large-scale peptide manufacturing. These
plans, alongside previous expansions made this year, aim to help Corden achieve its $1bn 2028 sales target.
Other companies such as Aurisco Pharmaceutical and Novo Nordisk have also made major investments in their
peptide manufacturing plants to meet the growing demand for GLP-1 receptor agonists.
Over the years, GLP-1 receptor agonist therapies have taken over the diabetes and weight loss fields, delivering
significant financial success for several companies. Novo Nordisk’s type 2 diabetes therapy Ozempic
(semaglutide) earned the company approximately $14bn in global sales last year while Eli Lilly’s Mounjaro
(tirzepatide) amassed $5.16bn in global sales in 2023. GlobalData’s consensus forecasts predict that global
sales for the therapies could reach $22.43bn and $27.42bn in 2030 respectively.
PAGE 16
GERMAN CDMO OUTLAYS $980M ON GLP-1 MANUFACTURING EXPANSION
As the EU anticipates GLP-1RA shortages throughout 2024, Corden Pharma has pledged $980m to increase
manufacturing capacity.
Pharmaceuticaltechnology.com,16 July 2024
HEALTHCARE DRUG APPROVAL CDMO &CRO
BIOLOGICS OTHERS
PAGE 17
WHY INDIAN CROS AND CDMOS STAND TO GAIN FROM THE US BIOSECURE ACT
Businesstoday,16 July 2024
The US Biosecure Act, if passed, is set to create substantial
opportunities for Indian contract development and manufacturing
organisations (CDMOs), according to pharmaceutical analysts.
The Act aims to reduce US biopharmaceutical reliance on China
and restrict technology transfer. Specifically targeting five Chinese
giants—WuXi Apptec, Wuxi Biologics, BGI, MGI, and Complete
Genomics—the Act bars firms collaborating with these companies
from receiving US government grants, loans, or contracts, though
existing contracts may be honoured for up to eight years.
Analysts Niharika Agarwal, Yogesh Soni, and Praful Bohra from InCred Equities emphasise that this legislative
move will deter US pharmaceutical companies from outsourcing to China, thereby promoting significant
opportunities for Indian CDMOs.
Major US players such as Merck, Vertex, and Gilead have already disclosed potential disruptions in their
Securities and Exchange Commission (SEC) filings. With approximately 120 US biopharmaceutical drugs
currently developed in partnership with Chinese CDMOs, the Act could lead to higher drug prices and extended
development cycles, the report said.
The CDMO market, growing faster than the global pharmaceutical sector, is seeing robust demand from
emerging biotech and biopharmaceutical enterprises that lack the resources to establish their own manufacturing
units. Leveraging cost advantages and government incentives like the production-linked incentive (PLI) scheme,
Indian CDMOs are expected to benefit immensely in the medium to long term, according to the InCred analysts.
The Indian CDMO market is valued at approximately Rs 18,800 crore in 2024 and is expected to see substantial
growth to reach Rs 37,200 crore by 2029, expanding at a robust CAGR of 14.67%. Globally, the CDMO market
stands at approximately Rs 2.03 lakh crore in 2024 and is projected to grow to Rs 2.77 lakh crore by 2029, at a
CAGR of 6.41%. India’s CDMO sector is outpacing global growth, according to market research firm Mordor
Intelligence.
Similarly, India Ratings and Research (Ind-Ra) also projects a surge in orders for Indian companies in the
CDMO and contract research organisation (CRO) segments from US pharmaceutical firms over the next 12-18
months following the potential enactment of the US Biosecure Act. The shift is also anticipated to disrupt the
supply of numerous trial drugs and essential raw materials, presenting Indian companies as viable alternatives.
HEALTHCARE DRUG APPROVAL CDMO &CRO
BIOLOGICS OTHERS
PAGE 18
Vivek Jain, Ind-Ra’s Director of Corporate Ratings, highlighted that the downturn in capacity utilisation over
FY22 and FY23 due to heightened capital expenditures has rebounded in FY24. Companies are now reaping the
benefits of operating leverage, which improves margins and cash flows, despite consistent debt levels, per Ind-
Ra. “We have upgraded three entities in the past year as their credit metrics improved,” Jain said.
Over the past two years, Indian companies have ramped up investments in capital expenditures, leading to
higher leverage ratios. However, Ind-Ra predicted these ratios will stabilise as the advantages of operating
leverage continue to enhance financial performance.
Signs of this positive trend are already visible, with more than 60% of listed pharmaceutical firms reporting
increased business enquiries. Furthermore, 33% believe the enactment of the Biosecure Act could significantly
drive their business, the agency said.
Ind-Ra’s analysis indicated that while the CDMO sector benefited from global China+1 diversification during
FY24, the CRO sector faced challenges, particularly due to weaker biotech funding. Both sectors, however,
have seen substantial capital investments, supported by government grants and interest-free loans aimed at
North American onshoring initiatives.
Although the debt levels of these firms may remain elevated due to substantial forthcoming capex, improved
capacity utilisation and enhanced credit metrics are expected to substantially strengthen their financial standing
in the coming years, Ind-Ra report said.
In June, GlobalData, a data and analytics company, raised alarms over the US Biosecure Act's potential to
impact more than 120 biopharmaceutical drugs developed in collaboration with Chinese firms flagged as
"companies of concern." As these biopharmaceutical giants scramble to diversify their supplier base before the
2032 deadline, CDMOs based outside China are set for substantial growth, the firm said. “Indian CDMOs such
as Cipla, Syngene, and Aurobindo may be well-positioned for increased growth due to their cost-effectiveness
and highly skilled workforce. However, growing concerns about US dependency on offshore suppliers may
also result in a shift towards US companies selecting domestic CDMOs,” said Alison Labya, a Business
Fundamentals Analyst at GlobalData.
HEALTHCARE DRUG APPROVAL CDMO &CRO
BIOLOGICS OTHERS
PAGE 19
J&J Q2 RESULTS: PHARMA MAJOR BEATS WALL STREET ESTIMATES ON
STRONG DRUG SALES
Johnson & Johnson beat estimates for second-quarter profit and revenue on
Wednesday, driven by strong sales of its drugs, including cancer treatment
Darzalex and blockbuster psoriasis drug Stelara.
Revenue of $22.4 billion surpassed the consensus estimate of $22.3 billion, according to LSEG data.
Adjusted earnings of $2.82 per share beat analysts' expectations of $2.70 per share
Stelara sales rose 3.1% to $2.89 billion, topping analysts' estimate of $2.77 billion according to LSEG data.
Darzalex sales rose 18.4% to $2.88 billion, in line with analysts' average estimate of $2.86 billion.
The New Jersey-based drugmaker said it now expected total 2024 sales of $89.2 billion to $89.6 billion,
compared with its prior forecast of $88.7 billion to $89.1 billion.
J&J also lowered its annual per-share forecast to a range of $10 to $10.10 from $10.60 to $10.75, to account
for a 5-cent increase from improved performance and a decrease of 68 cents related to costs from mergers and
acquisitions including its $13 billion purchase of cardiac medical device company.
That was among J&J's several deals this year, including its May purchase of experimental skin disorder drugs
in two acquisitions worth $2.1 billion. Sales for its medical technology business rose 2.2% to $7.96 billion
from $7.79 billion a year earlier, but fell short of analysts' estimate of $8.17 billion.
STELARA TO FACE RIVALS
Analysts expect Stelara sales of more than $10 billion this year, but this could fall to about $7 billion in 2025
when as many as six close copies of the drug are due to launch in the U.S.
J&J Chief Financial Officer Joe Wolk said he expected to finalize contracts within the next three months that
would determine favorable U.S. insurance coverage for Stelara in 2025.
"I'll remind you that we are still calling for growth in our pharmaceutical business despite the biosimilar
competition that we intend to encounter next year," he said.
.
Theeconomictimes,17th July 2024
HEALTHCARE DRUG APPROVAL CDMO &CRO
BIOLOGICS OTHERS
Darzalex, a blood cancer therapy launched in 2015, is expected to bring in sales of more than $11 billion for
J&J this year, analysts said. Despite falling 8.5% from last year's quarter, sales of J&J's cancer drug
Imbruvica reached $770 million, beating analysts' estimate of $718 million.
The company's cancer cell therapy, Carvykti, generated sales of $186 million, up nearly 60% from a year
earlier, but fell short of the $201 million analysts had predicted.
Tight supply has limited Carvykti sales, with the company working to boost production capacity at its plants
in New Jersey and Belgium.
