Acquisitions /mergers/joint-ventures

Viropro (San Jose, CA, USA) has signed a non-binding letter of intent to acquire NovaRx (San Diego, CA, USA), a pioneer immuno-oncology company for an undisclosed all stock transaction. NovaRx has developed a proprietary method of activating the immune-system to recognize and destroy cancer cells. Viropro also indicated that it has begun the process of renaming itself Axxiom.

Pfizer has confirmed that it is “in preliminary friendly discussion with Allergan in relation to a potential transaction” following a report from the Wall Street Journal and intensive media coverage. A merger with Dublin based Allergan would bring the tax inversion back on the political scene.

Business

Allergan (Dublin, Ireland) acquires European development and marketing rights to Ironwood Pharmaceutical’s (Cambridge, MA, USA) Constella or linaclotide from Almirall (Barcelona, Spain) in Europe. Constella, which was approved in 2012 by the European Commission, is the only prescription drug approved for irritable bowel syndrome with constipation (IBS-C). The license agreement includes the treatment of IBS-C, chronic idiopathic constipation and other gastrointestinal conditions. Allergan and Ironwood co-develop and co-commercialize linaclotide under the brand name Linzess in the US.

Ipsen (Paris, Boulogne-Billancourt, France) has entered a license agreement with Telesta Therapeutics (Pointe-Claire, Québec) for MCNA as a treatment for high-risk non-muscle-invasive bladder cancer. MCNA is a biologic therapy that is derived from the cell wall fractionation of a non-pathogenic bacterium. Under the terms of the deal Ipsen will get an exclusive license except for the Telesta’s territories (US, Canada, Mexico, South Africa and Japan) and will pay an $10 million upfront and up to $127 million in development contingent milestones as weel as tiered double-digit royalties on sales.

Vertex Pharmaceuticals (Boston, MA, USA) and CRISPR Therapeutics (Cambridge, MA, USA) have entered a collaboration on the research and development of novel therapies against sickle cell disease and cystic fibrosis in using CRISPR gene-editing technology. Vertex will pay $105 million upfront- on which $75 million in cash and the remaining $30 million as an equity investment- and potential development and regulatory milestones of up to 2.52 billion plus sales royalties.

Kite Pharma (Santa Monica, CA, USA) and Alpine Immune Sciences (Seatlle, WA, USA) enter into a research and development agreement on novel cancer immunotherapies. Under the terms of the agreement Alpine Immune Sciences will receive a $5 million upfront payment and subsequent development and regulatory milestones of up to $530 million as well as sales royalties.

MedImmunne and Igenica Biotherapeutics (Burlingame, CA, USA) have entered a research agreement to develop novel antibody-drug conjugates in using both companies in house technologies. Igenica will receive an undisclosed exclusive option fee plus an upfront license fee, milestones and sales royalties if MedImmune exercises its licensing option.

Zai Lab (Shanghai, China) enters a partnership with the Tsinghua University Immunology Institute to discover and develop new drugs and shows an inflection in its overall strategy which was predominantly an in-licensing model since the launch of the company in 2013. The new R&D center will be located at in Zhangjiang Hi-Tech Park in Shanghai-Pudong, and focus on "immunology discovery research and drug development in China." Financial details of the agreement were not disclosed.

ChinaMediTech (Hong-Kong, China) gets a $10 million milestone payment from Eli Lilly for the successful proof of concept study of fruquintinib (HMPL-013) – an orally active small molecule inhibitor of the vascular endothelial growth factor receptors (VEGFRs) – to treat non-small lung cancer. In March, Chi-Med said it had met the primary endpoint of progression-free survival in a Phase II clinical trial for colorectal cancer candidate fruquintinib putting it one step closer to China approval, which would be the first modern drug, since artemisinin for the treatment of malaria and which got Nobel Prize recognition last month, discovered and developed in China.

Approval of drugs, vaccines, diagnostics and devices

US FDA approves:

• Janssen Biotech’s Yondelis or trabectedin as a treatment for patients with unresectable liposarcoma.

• Alexion Pharmaceuticals’ Strensiq or asfotase alpha, an enzyme replacement therapy, which had breakthrough status, for use in patients with perinatal-onset, infantile-onset and juvenile-onset hypophospatasia, a rare metabolic bone disease. The drug was already approved in Europe and Japan.

• Amgen’s Imlygic or talimogene laherparepvec, a genetic modified oncolytic viral therapy, as a treatment of lesions in advanced melanoma.

• Novartis’ combination bronchodilator Utibron Neohaler (indacaterol/glycopyrrolate) inhalation powder for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). It is not approved for the treatment of asthma or sudden symptoms of COPD.

European Commission has granted:

• Vermillion (Austin TX, USA) CE mark approval to market Overa test for detecting ovarian cancer.

Drugs at clinical stage

US FDA Arthritis Advisory Committee recommends the approval of AstraZenca’s lesinurad in combination with febuxostat, a xanthine oxidase inhibitor, for the treatment of gout-associated hyperuricemia.

European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has endorsed Janssen Therapeutic’s Edurant or rilpivirine as a treatment for HIV-1 in patients 12 to 17 years old whose viral load is less or equal to 100,000 at start of the treatment.

Japan’s Ministry of Health, Labor and Welfare (MHLW) indicated that it had granted fast track status to six new drugs under its new “sakigake” review system. The named drugs are Keytruda from Merck & Co for the treatment of advanced unresectable gastric-cancer; ASP2215 from Astellas Pharma for the treatment of FL3 gene mutation-positive acute myeloid leukemia; BCX7353 from Integrated Development Associates;S-033188 from Shionogi for influenza virus infection; NS-O65/NCNP-01 from Nippon Shinyaku for the treatment of Duchenne muscular dystrophy and Sirolimus from Nobel Pharma for the treatment of angiofibroma.  To be reviewed under the new ”sakigake” system a product must display a novel mechanism of action, be scalable commercially, show high efficacy and be developed and planned for approval in Japan ahead of the rest of the world.

Science and Technology

Researchers from MIT and Massachusetts General Hospital have found an improved way to deliver drugs to the gastrointestinal tract using ultrasound waves a technique known as transient cavitation. The main delivery method for these GI disorders requires a patient to maintain a drug infused via an enema in the colon for hours while the drug is absorbed. The ultrasound waves create the formation of tiny bubbles that implode, jetting the medication into tissue, allowing much quicker absorption and less discomfort for the patient. This technique has been used for many years to aid delivery through the skin.

Pfizer teams up with GlaxoSmithKline to develop a next-generation portable, continuous miniature and modular (PCMM) prototype for pharmaceutical manufacturing. Pfizer's current PCMM prototype is an autonomous transportable pod that can be shipped from location to location and quickly brought online creating a fully functional GMP-compliant module. GSK’s resources and know-how will help create a next-generation design. A PCMM facility has a 70% smaller footprint compared to a conventional manufacturing facility while enabling the same equipment to be used for development, clinical trials and commercial manufacturing. It takes about one year to set up versus two – three years for standard processes.

Medical Devices and Diagnosis News

Flowonix Medical (Mount Olive, NJ, USA) has entered into a collaboration with Cerebral Therapeutic’s (Aurora, CO, USA) to develop an implanted drug delivery system for targeted micro-dosing administration of small molecules to the brain. Refractory epilepsy will be the main target of the drug delivery alliance. “Oral epilepsy treatment is ineffective in 20% of patients, and 30% to 40% of them are noncompliant with their drug regimen”, according to a company statement. Flowonix has already developed Prometra and Prometra II infusion pumps which allow for very precise dosing of morphine to the intrathecal space in the spine. 

According to the Institute of Cancer Research (ICR) genetic testing could identify young men who are at risk of a relapse from testicular cancer. Dr Clare Turnbull, senior researcher at the ICR, said: “Applying the 25 available variants, we found that men in the top one percent for testicular cancer risk were at a more than ten-fold elevated risk of developing the disease compared with the average”. 

Cost, Pricing and Market Access

A petition from UK charity Breast Cancer Now, signed by 42,000 people, is urging Roche to cut the price of its breast cancer drug Kadcyla.  Kadcyla (trastuzumab emtansine) is estimated to cost more than £90,000 per patient at its full list price, which caused NICE to reject the treatment. In a statement, the charity added: “Breast Cancer Now believes responsibility lies with the manufacturer to drop the price to a level that the NHS can afford and it remains hopeful that there is still time for Roche and the NHS to reach an agreement before Kadcyla is removed from the fund permanently. 

US Senators are asking the Federal Trade Commission (FTC) to investigate into possible illegal price inflation in the market of saline solutions for hospital use. They say price of these commonly used intravenous hydration dilution have risen 200-300% since a 2013 shortage.

Merck & Co offers UK NHS discounts and rebates amounting to £48 million on £191 million sales of its arthritis drug Remicade in the wake of the launch of two biosimilars of its blockbuster drug. According to Steinar Madsen, medical director at the Norwegian Medicines Agency, the Norwegian government is funding a study to observe the effects of moving from Remicade to a biosimilar and is expected to publish results in the third quarter of 2016.

Miscellaneous

Q3 Results from European Companies:

• Novartis revenues off by 6%, net income down by 42%, mainly due to a $390 million settlement payment in the US.

• GlaxoSmithKline revenues up by 9%, net income up by 68%. GSK will host an R&D event on November 3, 2015.

• Sanofi revenues up 9.2%, net income up by 8.3%. Global diabetes sales expected to decrease at an average annualized rate of 4 to 8% over the 2015-2018 period. Meet Management Seminar with strategic and financial outlook for the Group will take place in Paris on November 6, 2015.

Cellectis (Paris, France) implements a GMP manufacturing process for its lead candidate UCART19, an allogeneic engineered CART cell product in development for the treatment of hematological malignancies.

According to Global Data reports:

–       the worldwide market for Clostridium difficile infection treatment and prophylaxis valued at $356.3 million in 2014 will increase to $1.5 billion in 2024, mainly due to the introduction of non-antibiotic treatments and new infection-specific antibiotics.

–      the worldwide market for multiple myeloma treatment will grow from $8.9 billion in 2014 to 22.4 billion in 2023 with the introduction on new therapies such a Empliciti and daratumumab both expected to be launched in 2016 and to reach blockbuster status with peak sales of $4.2 billion and $3.7 billion respectively.

Bioevents

• BIO Europe 2015 on November 2-4 in Munich (Germany)
• BIO Pharma India Convention 2015 on November 3-4 in Mumbai (India)
• BIO Latam on November 16-17 in Santiago (Chile)
• Medica and Compamed on November 16-19 in Düsseldorf (Germany)
• Biofit 2015 on December 1-2 in Strasbourg (France)

And some early 2016 Events

• 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
• BIO Europe Spring on April 4-6 in Stockholm (Sweden)
• BIO Vision on April 13-14 in Lyon (France)
• BIO-IT World Conference & Expo’16 on April 5-7 in Boston (USA)

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)

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

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