Biopharmaceutical News Week 49

Acquisitions /mergers/joint-ventures/divestments

MundiPharma established a MundiPharma Ophthalmology business (Singapore) by acquiring Merck’s portfolio of glaucoma products in Australia, Canada, Latin America, Middle East, Africa and New Zealand. Terms of the deal were not disclosed. This transaction completes the divestiture of MSD's global ophthalmology business “as we continue to sharpen our focus in core markets and therapeutic areas and advance our innovative pipeline." said Ms Muna Bhanji, president, Hospital and Specialty Care, MSD.

Almirall (Barcelona, Spain) acquires Poli Group for €365 million and up to €35 million in milestones. The Poli Group comprises three operating companies Taurus Pharma, Polichem SA and Polichem Srl. Almirall also obtains a dermatology focused R&D structure and three clinical stage pipeline projects. This strategic transaction indicates that Almirall continues to execute its plan to become a major dermatology player in the biopharmaceutical industry. The transaction will be funded by using Almirall’s cash balance.

Business

Heptares Therapeutics (Welwyn Garden City, UK) signs a deal with Pfizer on the research and development of novel therapies across several therapeutic areas based on G protein-coupled receptors (GCPRs). Heptares will use its technology to produce StaR proteins – stabilised GPCRs that greatly improve thermostability without modifying biological activity – for up to 10 targets selected by Pfizer. Under the terms of the agreement, Heptares will receive an undisclosed upfront payment, milestones of up to $189M per target and tiered royalties on commercial sales. At the same time Pfizer Seiyaku KK has entered into an equity agreement, under which it will buy $33 million of newly issued common stock at a 25% premium price from Sosei Therapeutics (Tokyo, Japan), who acquired Heptares in February for $400 million.

….and with Teva Pharmaceutical for the development of small molecules calcitonin gene-related peptide (CGRP) antagonist for the treatment of migraine. CGRP is a neurotransmitter that is elevated and probably involved during migraine attacks. Blocking the peptide activity could prevent migraine attacks. The Heptares candidates will complement Teva's own CGRP programme, led by TEV-48125, an injectable antibody currently in phase 3 clinical trial. There has not been a new class of anti-migraine drugs since the development and marketing of the triptan class in the 1990s, but while these can treat attacks they are not very effective for prevention. Under the terms of the deal, Teva will pay a $10 million upfront and up to $400 million in milestone fees.

Zai Lab (Shanghai, China) and Hanmi Pharm (Seoul, South Korea) have entered a license agreement to develop HMG61713, a third generation irreversible EGRF mutant selective tyrosine kinase inhibitor, to treat lung cancer tumors with T790M mutations. Terms of the deal were not disclosed.

Oramed (Jerusalem, Israel) sells the Chinese rights of its oral insulin product to Sinopharm (Beijing, China) for $50 million. Under the terms of the deal Oramed will receive a $3 million upfront, a further $8 million in near-term installments and up to $26.5 million in milestones as well as 10% royalties on sales. In addition Sinopharm will invest $12 million in Oramed’s stock.

Kalobios Pharmaceuticals (South San Francisco, CA, USA) acquires rights for benznidazole an investigational drug for the treatment of Chagas disease from Savant Neglected Diseases, a privately-held specialty pharmaceutical company for $2 million upfront, and undisclosed milestones and sales royalties.

Polyphor (Allschwil, Switzerland) announces the extension of its R&D collaboration with Novartis to develop Protein Epitope Mimetic drug candidates.

…and sees Roche dropping out of the ongoing antibiotic development deal of RG7929/POL7080 for treating severe Pseudomonas aeruginosa infections. The rights to POL7080, which is currently in Phase 2, will be returned to Polyphor.

Roche and Proximagen (Cambridge, UK) a unit owned by Upsher-Smith Laboratories (Mapple Grove, MN, USA) have entered an agreement to develop a novel small molecule vascular adhesion protein 1 inhibitor against various inflammatory diseases. Under the terms of the deal Proximagen will receive an undisclosed upfront payment, milestones and sales royalties.

Boehringer Ingelheim (Ingelheim am Rhein, Germany) partners with University of Texas MD Anderson Cancer Center in Houston to discover and develop novel therapies and biomarkers to accurately identify and treat pancreatic cancer patients.

GSK and the US National Institute of Allergy and Infectious Diseases (NAID) partner to develop novel broadly neutralizing antibodies as preventive treatment for HIV.

Protagen (Dortmund, Germany) joints the MATURA (MAximising Therapeutic Utility for Rheumatoid Arthritis) consortium to support identification of treatment response predictors and stratification of patients with Rheumatoid Arthritis.

Approval of drugs, vaccines, diagnostics and devices

European Commission approves:

Biogen’s (Cambridge, MA, USA) and Swedish Orphan Biovitrium known as Sobi (Stockholm, Sweden) Elocta, a recombinant factor VII Fc therapy, for as an on-demand and preventive therapy for haemophilia A patients. Haemophilia A is a rare, chronic, genetic disorder in which the ability of a person's blood to clot is impaired due to missing or reduced levels of protein known as factor VIII.

…and GlaxoSmithKline’s Nucala or mepolizumab as an add-on treatment for severe refractory eosinophilic asthma. Mepolizumab is the first and only approved biologic therapy that targets IL-5, the main promotor of eosinophil growth and activation, which blocks the binding of IL-5 to its receptor, thereby interrupting the inflammation pathway.

US FDA approves:

Bristol-Myers Squibb’s and AbbVie’s Empliciti or elotuzumab (who had breakthrough status) in combination with Celgene’s Revlimid (lenalidomide) and dexamethasone in second line for the treatment of multiple myeloma patients. Elotuzumab is an immuno-stimulatory antibody targeting SLAMF7, a cell-surface glycoprotein that is highly expressed on myeloma cells and Natural Killer cells, but not on normal solid tissues or on haematopoietic stem cells. Emplici is, with Darazalex from J&J and Ninlaro from Takeda, the third drug to be approved by the US FDA for this indication within the last month.

…and CSL vaccines business Segirus’ (Melbourne, Australia) Fluad the first publicly available adjuvanted seasonal flu vaccine. Use of adjuvants has encountered rather severe resistance in the US over the years because of concerns with side effects of various ingredients.

Drugs at clinical stage

NovoNordisk’s Victoza or liraglutide showed superiority in blood glucose lowering in diabetic patients across 17 randomised controlled trials when assessed against Johnson & Johnson’s Invokana (canagliflozin), Lilly/Boehringer’s Jardiance (empagliflozin) and AstraZeneca's Farxiga (dapagliflozin).

US FDA:

suspends the clinical development of Zafgen’s (Boston, MA, USA) beloranib, an anti-obesity drug after a second death occurred in a US Phase 3 trial. Beloranib is an analog of the natural product fumagillin, which acts as a methionine aminopeptidase 2 (METAP2) inhibitor. The drug was originally designed for the treatment of various cancer diseases but had also shown anti-obesity activity.

grants Cellceutix’s (Beverly, MA, USA) Kevetrin, a small molecule P53 activator, rare pediatric designation for use in treating retinoblastoma.
grants Trevena’s (King of Prussia, PA, USA) TRV130 or oliceridine, a biased µ opiod receptor ligand, fast track designation for the use of managing moderate to acute pain.
grants Lysogene‘s (Paris, France) LYS-SAF-302, an adeno-associated virus gene therapy product, orphan designation for the treatment of Sanfilippo Type A disease also known as mucopolysaccharidosis type IIIA.

European Medicine Agency grants orphan status to:

Aduro Biotech’s (Berkeley, CA, USA) immunotherapy CRS-207, for the treatment of mesothelioma, a rare form of cancer most commonly caused by exposure to asbestos.
Advaxis’ (Princeton, NJ, USA) ADX-HER2, an investigational immunotherapy agent for the treatment of osteosarcoma, the most common form of primary bone cancer.ADXS-HER2 is an attenuated bioengineered Listeria monocytogenes bacteria which delivers a fusion protein inside cancer cells and stimulates the immune system.
Merck KGaA and Pfizer’s avelumab for the treatment for Merkel cell carcinoma (see newsletters # 48, 47, 41 and 39 for recent reports on the treatment of this rare disease).

Cost, Pricing and Market Access

UK National Institute for Healthcare and Care Excellence (NICE):

recommends Novartis’ Farydak, or panobinostat combined with Velcade and dexamethasone as an option to treat relapsed or refractory multiple myeloma after an initial rejection earlier this year. The endorsement is dependent on the provision of the drug with the discount agreed in the patient access scheme, which secures its cost effectiveness. Farydak targets enzymes known as histone deacetylases, offering a novel mechanism of action different from other recently approved multiple myeloma treatments (see above)

…but rejects Alexion Pharmaceutical’s (Chesire, Conn, USA) Strensiq (asfotase alfa) for the treatment an ultra-rare bone disorder called paediatric-onset hypophosphatasia (HPP). HPP is a genetic disease characterised by defective bone mineralisation that leads to destruction and deformity of bones, profound muscle weakness, seizures, respiratory failure and premature death. With a yearly total cost of treatment at £366,912 (about $550, 400) the NICE Committee “was unable to estimate from the clinical evidence the precise size of these benefits that are relevant for patients in the longer term,” and “was not satisfied that the company had not provided an adequate justification for the high cost per person of asfotase alfa, or for the overall cost to the NHS in terms of what could be expected to be reasonable in the context of a highly specialised service”.

Bristol-Myers Squib received US approval for Empliciti for the treatment of multiple myeloma earlier this week (see above) and puts a price tag of $142,000 for the first year of treatment for the drug which includes a two month induction period. That price tag puts the drug in line with that of Darzalex at $135,550, Pomalyst at $147,302 and Kyprolys at $114,000 for a year of treatment of the disease.

Praluent versus Repatha: Round 3 for Sanofi/Regeneron. Amgen’s Repatha had earlier scored favorably with CVS Health and Harvard Pilgrim Health System (see newsletter #48) but now Sanofi/Regeneron’s Praluent makes it as the preferred product with UnitedHealth Oxford unit, a US pharmacy benefit manager, in an innovative way. Within the arrangement Praluent should be given as a first intention, unless patients have a history of reacting badly to it. If Praluent doesn't work after 12 weeks, patients should be switched to competing drug Repatha from Amgen.

In a report from The Washington Post, claiming an investigation released by Republican Sen. Charles Grassley and Democrat Sen. Ron Wyden, concerning the pricing of Gilead Sciences’ Sovaldi and Harvoni for the treatment of hepatitis C, Wyden said “it was always Gilead's plan to max out revenue, and that accessibility and affordability were pretty much an afterthought." Gilead spokeswoman Michele Rest replied in The Philadelphia Inquirer that "Gilead responsibly and thoughtfully priced Sovaldi and Harvoni” and also said “that 600,000 patients have been treated by Sovaldi or its higher-priced follow up Harvoni and that it has programs to assist uninsured patients get the drug”.

Miscellaneous

Samsung Biologics will spend at least $736 million to build a new manufacturing plant in Songdo (South Korea) with 180,000 liter capacity and has the ambition to become the world's largest contract biologics manufacturer. The current plans are also located in Sondgo, one of them, already approved by the US FDA, has a 30,000 liter capacity and is producing biologics drugs for Merck, Roche and Bristol-Myers Squibb. The new facility will be completed in 2018.

GlaxoSmithKline has delayed the launch of Zagallo or dutasteride for the treatment of androgenic alopecia in Japan because of the suspension, on November 13^th, by the French health authorities of the Catalent’s manufacturing facility in Beinheim (France) (see newsletter #47)

Bioevents

Events in 2016

BIOTech ShowCase 2016 on January 11-13 in San Francisco (USA)
JP Morgan 33^rd Annual Healthcare Conference on January 12-16 in San Francisco (USA)
BIO CEO Investor Conference on February 8-9 in New York City (USA)
BIO Asia 2016 on March 15-16 in Tokyo (Japan)
Global Healthcare Forum on March 16-17 in Singapore (Singapore)
BIOPharma Asia Convention on March 22-24 in Singapore (Singapore)
BIO Europe Spring on April 4-6 in Stockholm (Sweden)
BIO-IT World Conference & Expo’16 on April 5-7 in Boston (USA)
BIO Vision on April 13-14 in Lyon (France)
BIO Trinity on April 25-27 in London (UK)
Strategic Alliance Management Congress on May 16-18 in Philadelphia (USA)
China BIO Partnering on May 18-19 in Suzhou (China)
BIO International Convention on June 6-9 in San Francisco (USA)
BIO Pharm America on September 13-15 in Boston (USA)
7^th Innovation Days on October 3-4 in Paris (France)
Biofit 2015 on November 30, December 1 in Lille (France)

IMPORTANT NOTICE: This document has been prepared by btobioinnovation and is provided to you for information purposes only. The information contained in this document has been obtained from sources that btobioinnovation believes are reliable but btobioinnovation does not warrant that it is accurate or complete. The views presented in this document are those of btobioinnovation’s editor at the time of writing and are subject to change. btobioinnovation has no obligation to update its opinions or the information in this document.

Author: Jean-Claude Muller, Special Advisor at I&IR, jcm@btobioinnovation.com

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