1. Visium’s Valvani Charged with
Insider Trading on FDA Leaks
U.S.
Attorney Preet Bharara in Manhattan charged Sanjay Valvani of Visium Asset
Management LP of fraudulently making $25 million by gaining advance word about
U.S. Food and Drug Administration approvals of generic drug applications from
2005 to 2011. The case is one of the biggest insider trading cases since a 2014
court ruling made it more difficult for U.S. prosecutors to pursue traders and
prove them guilty. Prosecutors assert that Valvani obtained inside information
from consultant Gordon Johnston, who had contacted a former colleague and
friend at the FDA. Valvani subsequently passed a portion of this information to
Christopher Plaford, then a Visium portfolio manager, who made his own illegal
trades. Johnston and Plaford have pleaded guilty to related charges and are
cooperating with prosecutors. Stefan Lumiere, another former Visium portfolio
manager, was charged with securities fraud, wire fraud and conspiracy, and
freed on $1 million bond, but did not enter a plea. Valvani pleaded not guilty
to five counts including securities fraud, wire fraud and conspiracy and was
freed on $5 million bond. http://www.reuters.com/article/us-usa-fraud-insidertrading-idUSKCN0Z11TB
2. Brexit spells upheaval for EU and
UK drug regulation
Britain’s
vote to withdraw from the European Union, known as “Brexit,” spells uncertainty
for drug companies as the London-based European Medicines Agency (EMA) is
expected to have to relocate. Industry executives are concerned that the
upheaval of the EMA, which has overseen pan-European drug approvals since 1995
from its home in London, could complicate the EU’s drug approval process. There
is also a concern over how Britain will domestically regulate drugs going
forward. While the Brexit is not expected to negatively impact profits for global
drug manufacturers, many scientists are concerned that funding and
collaboration for academic research, which has been well supported by the EU in
recent decades, will now be jeopardized. http://www.reuters.com/article/us-britain-eu-corporates-pharmaceuticals-idUSKCN0ZA26J
3. Hunting growth, Samsung races to
get up to speed on biosimilar drugs
With
four-year-old Bioepis, South Korea’s Samsung Group hopes to offset a slowing
smartphone market and capture the potentially lucrative biosimilars market,
which is estimated to generate $26.6 billion global revenue by 2020 from $2.6
billion in 2014. Fixated on speed, Bioepis took only four years of development,
roughly two times faster than most biosimilars that come to market, to launch a
biosimilar version of Enbrel, Amgen’s blockbuster rheumatoid arthritis drug,
earlier this year. Bioepis has not shied away from taking risks, including mass
production ahead of clinical trials, and plans to make a U.S. initial public
offering over the next few years. With large pharmaceutical companies like
Pfizer dipping into the biosimilar market, Samsung must continue its
large-scale investment in Bioepis to succeed. http://www.reuters.com/article/us-samsung-group-biosimilars-idUSKCN0YS2JL
4. U.S. to invest $200 million to
shorten organ transplant wait lists
The U.S.
government plans to invest $200 million to help shorten the waiting list for
patients waiting for organ transplants. The investment will be led by the
Department of Defense and is designed to support technologies aimed at
repairing and replacing cells and tissues. More than $160 million will go to a
new Advanced Tissue Biofabrication Manufacturing Innovation Institute to help
develop next-generation manufacturing techniques for cell therapies and $7
million will be earmarked for awards to small businesses working to advance the
science of tissue preservation. The funding comes at an important time; more
than 120,000 people in the United States are currently on a donor waiting list
and just last year, the U.S. saw a record of more than 30,000 transplants. http://www.reuters.com/article/us-usa-transplants-idUSKCN0YZ1RY
5. House Republicans unveil
healthcare alternative to Obamacare
Republicans
in the U.S. House of Representatives recently introduced a proposal challenging
President Barack Obama’s signature 2010 Affordable Care Act. The proposal, part
of a broader effort by House Speaker Paul Ryan to maintain control of both the
House and the Senate before the upcoming November 8 presidential elections,
criticizes Obamacare for limiting patients’ choices, increasing consumer costs,
and burying employers and health care providers under new regulations. Although
it includes long-held Republican proposals such as allowing consumers to buy
health insurance across state lines, expanding health savings accounts, and
giving block grants to states to run Medicaid programs for the poor, the
alternative plan keeps some of Obamacare’s popular provisions, including not
allowing people with pre-existing conditions to be denied coverage and
permitting children to stay on their parents’ coverage until age 26. While
Democrats have dismissed Ryan’s proposals as merely trite ideas, industry
groups remain ready to work with both parties to improve access and affordability
for consumers, as the elections have yet to happen. http://www.reuters.com/article/us-usa-election-healthcare-ryan-idUSKCN0Z80AQ
6. Pfizer completes $5.2bn acquisition
of Anacor
Pfizer has
completed its acquisition of all outstanding common stock shares of the Silicon
Valley biotech group Anacor for $99.25 per share, equating to a total deal
value of about $5.2 billion. Through this acquisition, Pfizer has secured
access to the non-steroidal topical PDE4 inhibitor crisaborole, a treatment for
mild-to-moderate atopic dermatitis that is currently being reviewed by U.S.
regulators. A decision is expected in by January 7 of 2017 and Pfizer believes
the drug could achieve at least $2 billion a year if it makes it to market; it
is estimated that up to 25 million people in the U.S. suffer from atopic
dermatitis. http://www.pharmatimes.com/news/pfizer_completes_$5.2bn_acquisition_of_anacor_1049226
7. Shire, Baxalta Complete $32B
Merger
Shire has
completed its $32 billion merger with Baxalta, a biopharmaceutical business
focusing on treatments for orphan diseases and underserved conditions in
hematology, immunology, and oncology. Baxalta, which was spun off by Baxter
International in 2015, will now be an indirect wholly-owned subsidiary of
Shire. Shire, which currently has products in gastrointestinal/endocrine
diseases, hereditary angioedema, neuroscience, and lysosomal storage diseases,
maintains that this merger has made it the global market leader in rare
diseases, with the number one rare diseases platform based on both revenue and
pipeline programs. It projects that the combined company will generate
approximately 65% of its total annual revenues, which is forecasted to rise to
more than $20 billion by 2020. Within the next three years, Shire also plans to
cut more than $500 million in costs by increasing efficiency, scaling up of the
combined business, aligning Baxalta programs to Shire’s lean operating model,
and optimizing the combined R&D portfolio. http://www.genengnews.com/gen-news-highlights/shire-baxalta-complete-32b-merger/81252788/
8. Shire picks up two breakthrough
badges for rare disease drugs
U.S.
regulators have awarded Breakthrough Therapy badges to two of Shire’s
investigational products. The first is a novel formulation of budesonide for
eosinophilic esophagitis (EoE), a chronic rare disease resulting from an
elevated number of eosinophils that causes inflammation in the esophagus and
affects about 15-55 per 100,000 persons. Twelve weeks of the budesonide oral
suspension treatment in a Phase II trial has significantly reduced both
dysphagia symptoms and achieved higher proportion of subjects with histologic
response compared to placebo. The second drug is maralixibat (LUM001) for type
2 progressive familial intrahepatic cholestasis (PFIC), the most common type of
a group of child autosomal-recessive liver disorders that disrupt bile
formation and cause cholestasis. The conditions affect around 1 in 50,000 to 1
in 100,000 births, and PFIC2 is the most common type, accounting for around
half of cases. A Phase II study of LUM001-501 (INDIGO) in pediatric patients
with PFIC has shown decreases in a subpopulation of patients, reductions in
pruritus, and normalization of liver parameters in patients with liver enzymes.
http://www.pharmatimes.com/news/shire_picks_up_two_breakthrough_badges_for_rare_disease_drugs_1040537
9. India’s Dr Reddy’s in $350
million deal to buy eight U.S. drugs from Teva, Allergan
With an 86
percent slump in profit for its March quarter, India’s second-largest drugmaker
Dr Reddy’s Laboratories Ltd has agreed to purchase eight generic drugs from
Teva Pharmaceutical Industries and Allergan Plc for $350 million in cash to
bolster its slowing U.S. business. The products being divested consist of
generic drugs that have not yet been U.S. approved, as well as drugs that are
already on the market. Teva hopes to win the U.S. Federal Trade Commission’s
antitrust clearance for its $40.5 billion acquisition of Allergan’s generic
drugs portfolio through this deal with Dr Reddy’s. http://www.reuters.com/article/us-dr-reddys-m-a-teva-pharm-ind-idUSKCN0YX060
10. Sanofi, Boehringer to swap
animal, consumer health assets
Sanofi and
Boehringer Ingelheim have signed contracts to exchange their respective animal
health and consumer healthcare businesses. Sanofi’s Merial business, which is
valued at approximately 11.4 billion Euros, will be transferred to Boehringer
in return for 4.7 billion Euros and Boehringer’s CHC business, which is worth
around 6.7 billion Euros. Sanofi expects the transaction to be accretive after
2017, and forecasts joint CHC sales to be around 4.9 billion Euros. Boehringer
believes that by combining its portfolios and technology platforms in
antiparasitics, vaccines and pharmaceutical specialties with Merial’s, it will
be able to boost its competitiveness and increase its health sales by more than
two times, to bring in revenue of around 3.8 billion Euros. http://www.pharmatimes.com/news/sanofi,_boehringer_to_swap_animal,_consumer_health_assets_1049222
11. Takeda to Invest $65M in
Ultragenyx under Rare Disease Drug Collaboration
Takeda
Pharmaceutical has agreed to purchase $25 million of stock from Ultragenyx
Pharmaceutical along with a $15 million cash premium at closing and with a 12-month
period in between, purchase another $25 million with no additional premium. As
part of the strategic partnership between the two companies, Ultragenyx will
license and co-develop at least one and up to six Takeda product candidates for
rare diseases over a 5-year research collaboration period. Takeda will receive
an exclusive option to commercialize any licensed products developed through
the collaboration in Asia and an option to license one Ultragenyx pipeline
treatment in Japan. This collaboration provides Ultragenyx with a continued
source of product candidates and Takeda access to strong patient-centric
development and regulatory capabilities in the field of rare disease; Takeda’s
therapeutic areas consist of “general medicine,” including oncology,
cardiovascular and metabolic, central nervous system, gastrointestinal,
respiratory, immunology, and vaccines. Recently, the company has been actively
pursuing development for rare disease drugs, with its partnership with BioXcel
and collaboration with Kyoto University’s Center for iPS Cell Research
Application last year. http://www.genengnews.com/gen-news-highlights/takeda-to-invest-65m-in-ultragenyx-under-rare-disease-drug-collaboration/81252798/
12. Korean biopharma firms rush into
IPO market this year
The largest
number of stock market debuts by Korean pharmaceutical companies is expected
this year. The Korean pharmaceutical industry is expected to continue steady
growth as companies search for funds for global market expansion. Amid growing
market expectations, Green Cross LabCell and ST Pharm got the green light for
new listings on the tech-heavy KOSDAQ bourse Thursday. The two firms are part
of a long list of bio companies jumping into the initial public offerings
market; in the first half of 2016, five companies went public, raising a
combined $216 million through IPOs. In the second half of the year, heavy
lifters like Samsung BioLogics, Celltrion Healthcare, and CJ Healthcare have
indicated that they will be listing as well. Samsung BioLogics, in particular,
is expected to be one of the biggest IPOs this year, with industry analysts
estimating about 3 trillion won worth of shares in the IPO. The rush to raise
funds for R&D and production capacity increases by biopharmaceutical
companies in Korea represents the hopeful mood in the industry. http://www.koreaherald.com/view.php?ud=20160622001020
13. Global cancer drug spending to
exceed $150 billion by 2020: IMS report
In a global
oncology report released by IMS Health Holdings Worldwide, worldwide spending
on cancer medicines is expected to exceed $150 billion by 2020. This forecast
represents an annual global growth rate for oncology drug spending of 7.5
percent to 10.5 percent through 2020, up from last year’s prediction of 6
percent to 8 percent growth through 2018. Taking into account prescription
medicine list prices and supportive care drugs to address side effects, IMS
found that global oncology drug spending reached $107 billion in 2015, an 11.5
percent increase over the prior year and up from $90 billion in 2011. As cancer
is being redefined as a large number of narrowly defined diseases, many
expensive new therapies designed to improve patient immune systems have emerged
in the past five years, which is believed to be the cause of the dramatic
spending increases. http://www.reuters.com/article/us-health-cancer-spending-idUSKCN0YO0BQ
14. Medtronic to buy HeartWare for
$1.1 billion
Medtronic
PLC has agreed to acquire HeartWare International Inc. at a premium for $1.1
billion. The acquisition gives Medtronic more diagnostic tools and treatments
for heart failure. Over the past year, HeartWare’s stock has fallen 60% amid
declining sales, problems with product studies and a terminated acquisition.
The company creates ventricular assist devices (VAD) and serves a global VAD
market of about $800 million, which is expected to grow by a percentage in the
mid-to-high single digits this year and accelerate to a percentage in the
high-single, low-double digits in future years. The deal is expected to close
by late October and add to Medtronic’s earnings in its third year. http://www.wsj.com/articles/medtronic-to-buy-heartware-for-1-1-billion-1467029614
15. EU wants more transparency on
AbbVie’s Humira, world’s top drug
The
European Union’s ombudsman Emily O’Reilly recently announced that four specific
data redactions regarding clinical trial details of AbbVie’s rheumatoid
arthritis drug Humira, the world’s top-selling prescription medicine, are
unjustified. These data redactions were part of a 2014 deal between AbbVie and
the European Medicines Agency (EMA), when AbbVie dropped a lawsuit against the
EMA after the agency agreed to certain data redactions on the grounds of commercial
interest. Since 2010, the EMA has pushed for increased transparency, an
initiative that has remained ineffective after the 2014 case. In response to
O’Reilly’s statements, the EMA said it was pleased O’Reilly had found no
maladministration in its handling of the matter, adding there was no agreed
definition of commercially confidential data and that specific commercial
interests change over time. AbbVie, while mentioning its commitment to
responsible transparency, defended its previous actions, stating that there is
a need to protect commercially confidential information. In recent years, drug
companies around the world have come under increasing pressure to provide full
disclosure of clinical trial results, following complaints by doctors and
campaigners who believe access to such data is essential for consumers and
medical experts.
http://www.reuters.com/article/us-pharmaceuticals-europe-abbvie-idUSKCN0YW1D6