In our continuous endeavor to share
business intelligence that can help grow your pharmaceutical business, each
month PharmaCompass brings you a roundup of deals and investments from across the globe through our column — PharmaFlow.
Though the third PharmaFlow is
reaching you a tad bit late, we hope it provides you with an insight into the breakthrough
technologies and business trends of the future.
Generic drug makers continue to drive deal making
While debt-laden Teva led the deals in September through its disinvestment efforts, the biggest
pharma deal in October was also from the world of generics as Amneal decided to merge with Impax.
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With the intention to combat pricing pressure being faced by generic drug manufacturers, the
all-stock Impax-Amneal deal will create the fifth-largest generics player in the US. Though Impax shareholders will own 25 percent of the new company, the merged entity will retain Amneal’s name. The value of the deal was estimated at US$ 6.4 billion.
In a smaller
deal, Lupin acquired Symbiomix Therapeutics for US$
150 million to gain access to a women’s healthcare drug brand Solosec, which received US Food and Drug Administration (USFDA) approval in September 2017.
Solosec contains the antibiotic secnidazole and is
the first single-dose oral treatment for bacterial vaginosis, the most common
vaginal infection in women aged 15 to 44 years, according to the Centers for
Disease Control and Prevention.
Novartis bets
big on radiopharmaceuticals
Novartis bolstered its oncology portfolio in a field it is familiar with — neuroendocrine tumors. The Swiss drugmaker entered into a memorandum of understanding with French radiopharmaceutical company
Advanced Accelerator Applications (AAA).
Under the agreement, Novartis would make a cash offer for 100 percent of AAA’s share capital that valued the company at US$ 3.9 billion.
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AAA develops,
produces and commercializes molecular nuclear medicines including Lutathera — a therapy product for neuroendocrine tumors (NETs).
Based on the rare earth metal leutetium, radiopharmaceuticals (such as
Lutathera) are unique medicinal formulations that contain radioisotopes used
clinically for both diagnosis and therapy.
Lutathera was
approved in Europe in September 2017 and is under review in the US with a
Prescription Drug User Fee Act (PDUFA) date of January 26, 2018
AAA had sales of around US$ 129 million (Euro 109 million) in
2016.
Click here to view the major deals in October 2017 (Excel version available) for FREE
Will an orphan drug approved in Europe win FDA’s okay?
It isn’t uncommon for drugs which are approved for use outside the United States to get an approval from the FDA only years later.
Pitolisant, a
treatment for narcolepsy (a
rare, chronic, debilitating neurological disorder characterized by excessive
daytime sleepiness) was
approved in Europe last year. And biopharmaceutical company Harmony Biosciences
acquired the exclusive rights to develop,
register and market Pitolisant in the US from French company Bioprojet SCR.
Pitolisant is a
selective histamine H3-receptor antagonist/inverse agonist that enhances the
activity of histaminergic neurons (or neurons that have a wakefulness-related
firing pattern). Approved in the European Union, the drug is distributed under
the tradename Wakix. Currently no H3-receptor antagonist/inverse agonist has
been approved by the US FDA.
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Harmony
Biosciences, a member of the Paragon Biosciences corporate family, also
announced it completed a US$ 270 million equity financing to
facilitate this acquisition.
Eli Lilly teams
up with CureVac for cancer vaccines
The field of oncology saw several other
deals in October. The biggest deal was between Eli Lilly and Germany’s CureVac. Eli Lilly entered into a US$ 1.8 billion deal with CureVac to develop and commercialize up to five
potential cancer vaccine products based on CureVac's proprietary RNActive technology.
The technology uses messenger RNA (mRNA)
to instruct the human immune system to target tumor neoantigens (or antigens to
which the immune system has not previously been exposed) for a more robust
anti-cancer immune response.
CureVac will receive an upfront payment
of US$ 50 million and
an equity investment of Euro 45 million (US$ 53 million). CureVac is also eligible to receive more
than US$ 1.7 billion in development and commercialization milestones if all five vaccines are successfully developed, along with tiered royalties on product sales.
Click here to view the major deals in October 2017 (Excel version available) for FREE
On its
part, Lilly is responsible
for target identification, clinical development and commercialization while CureVac will undertake the mRNA design,
formulation and manufacturing of clinical supply. CureVac also retains the
option to co-promote the vaccine products in Germany.
In another deal focused on cancer therapy, Amgen announced a strategic collaboration
with CytomX Therapeutics in the area of immuno-oncology.
The companies will jointly collaborate on CytomX’s Probody antibody platform which drives precision biology by making
antibodies bind selectively to tumors, and not to healthy tissues, in order to
minimize toxicity and create safer, more effective cancer therapies.
While CytomX has announced various partnerships with major
pharmaceutical companies in the recent past, the agreement with Amgen will
focus on T-cell engaging bispecific against the Epidermal Growth Factor
Receptor (EGFR), a highly validated oncology target expressed on multiple human
cancer types.
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Amgen will make an upfront payment of US$ 40 million and purchase US$ 20 million worth of CytomX’s common stock. CytomX will be eligible to receive up to US$ 455 million in development, regulatory and commercial milestones for the EGFR program.
Deals were also struck between Incyte
and Macrogenics where Incyte gained exclusive, worldwide development and commercialization rights to an investigational monoclonal antibody that
inhibits programmed cell death protein 1 (PD-1).
Anti-PD-1 therapy is becoming a mainstay of cancer treatment
across multiple tumor types.
The month also saw Merck invest in KalVista’s drug for diabetic macular edema while Takeda
tied up with privately-held HemoShear Therapeutics for
a drug discovery collaboration for liver diseases, including nonalcoholic
steatohepatitis (NASH).
Click here to view the major deals in October 2017 (Excel version
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Roche
entered into a strategic collaboration with US-based Warp Drive Bio to deploy its proprietary ‘Genome Mining Platform’ to discover new antibiotics. Warp Drive’s platform enables access to natural product drugs that have not been analyzed previously, owing to historical technology limitations.
Warp Drive will receive up to US$ 387 million in upfront fees
and milestone payments.
Our view
A rapidly deteriorating business environment for generic drug makers had Teva’s divestments lead the list of deals announced in September. And once again in October, we find the merger of two generic drug makers emerge as the largest deal of the month.
With recent news that Novartis’ generic division Sandoz’s
oral solids business may be put on the block, we expect this trend to
continue. And, we will see a significant shift in who will continue to
manufacture generic medicines and how they will be distributed and sold.
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