Wednesday, December 19, 2018
Zimmer Biomet downgraded to Neutral from Overweight at JPMorgan
JPMorgan analyst Robert Marcus downgraded Zimmer Biomet Holdings to Neutral and lowered his price target for the shares to $118 from $140. The analyst believes the company’s long-term outlook is intact but he sees limited near-term upside.
https://thefly.com/landingPageNews.php?id=2838995
Bristol-Myers receives offer from Taisho to purchase UPSA for $1.6B
Bristol-Myers announced that Taisho Pharmaceutical Holdings has offered to purchase Bristol-Myers Squibb’s UPSA consumer health business for $1.6B. UPSA develops and delivers important consumer medicines for patients in France, across Europe and additional countries. Taisho is the largest over-the-counter drug company in Japan, with over a century of experience in this field. Taisho holds a leading presence in anti-inflammatory analgesic, cold and flu and hair growth segments in Japan and Southeast Asia. The potential transaction is anticipated to be completed during the first half of 2019, subject to regulatory approvals and satisfaction of certain other customary closing conditions. The offer by Taisho is structured in the form of a “put option” agreement. Under the terms of the agreement, the offer is subject to Bristol-Myers Squibb’s exercise of the put option following information and consultation processes with relevant employee representative bodies. Upon exercise of the put option, Bristol-Myers Squibb and Taisho would execute a definitive stock and assets purchase agreement following which Taisho would acquire all of the issued and outstanding shares of capital stock of UPSA SAS, as well as Bristol-Myers Squibb’s assets and liabilities relating to the UPSA product portfolio. Assuming completion, Bristol-Myers Squibb estimates the potential transaction would be approximately (4c) dilutive to 2019 earnings.
https://thefly.com/landingPageNews.php?id=2838997
Tuesday, December 18, 2018
Tetra Discovery, Shionogi Collaborate on Early Alzheimer’s, Fragile X
- Deal Valued at Potential $160 Million plus Royalties, including $5 Million in Upfront Payments and $35 Million in Equity Investment
- Shionogi Gains Regional License to Alzheimer’s Drug Candidate for Japan, Korea and Taiwan
- Collaboration to Accelerate BPN14770 Clinical Development in Fragile X Syndrome and Early Alzheimer’s Disease
Tetra Discovery Partners and Shionogi & Co., Ltd. today announced they have entered into a strategic collaboration for the clinical development and commercialization of BPN14770, Tetra’s selective phosphodiesterase-4D (PDE4D) allosteric inhibitor, for the treatment of Fragile X Syndrome, Alzheimer’s disease and other indications marked by cognitive and memory deficits. The goal of the collaboration is to accelerate the development of an innovative therapeutic for patients in key Asian markets.
In exchange for granting Shionogi development rights to BPN14770 in Japan, Taiwan and Korea, Tetra Discovery Partners has received $40 million in combined upfront funding, including an equity investment and licensing payment. Tetra will also be eligible to receive up to an additional $120 million in development and commercialization milestones, as well as royalties on sales if BPN14770 is successfully commercialized. Further financial details of the agreement were not disclosed.
Tetra is developing BPN14770 for the treatment of brain disorders marked by cognitive and memory deficits, including Fragile X Syndrome, Alzheimer’s disease and other dementias, learning/developmental disabilities, major depression, and schizophrenia. The company currently is conducting an investigational Phase 2 study of BPN14770 in adults with Fragile X Syndrome, an indication for which BPN14770 has received Orphan Drug Designation from the U.S. Food and Drug Administration. Preparations are also under way to initiate a Phase 2 trial of BPN14770 in patients with early Alzheimer’s disease.
“We are very pleased to join forces with Shionogi, a company that shares our interests in developing innovative medicines for patients with debilitating central nervous system (CNS) conditions,” said Mark Gurney, Ph.D., Chairman and Chief Executive Officer of Tetra Discovery Partners. “Shionogi scientists contributed greatly to fundamental discoveries concerning the biochemical pathway modulated by BPN14770. The company’s in-depth knowledge of this brain pathway and focus on CNS drug development makes Shionogi a very compelling partner for Tetra. We greatly look forward to collaborating with them to accelerate the development of BPN14770 and to broaden geographic access to a potentially important new therapeutic.”
Dr. Gurney noted that the new funding will enable Tetra to complete its ongoing Phase 2 trial in Fragile X Syndrome and to initiate a Phase 2 trial of BPN14770 in patients with early Alzheimer’s disease in early 2019.
“This collaboration, if successful, will enable us to move one step closer in realizing a more vigorous society in which patients can be relieved from debilitating central nervous system (CNS) conditions,” said Dr. Isao Teshirogi, President and Chief Executive Officer, Shionogi & Co., Ltd. “In addition, the compound will allow us to further strengthen the presence in the CNS area that we have built up with Cymbalta and Intuniv.”
Orphan Drug Exclusivity Works As Intended; On-Market Prices Rise Slower
A new report commissioned by the National Organization for Rare Disorders (NORD) and published today by the IQVIA Institute, demonstrates that the seven-year market exclusivity granted to drugs designated under the Orphan Drug Act of 1983 for rare diseases is working as intended. In nearly every case, orphan exclusivity did not inappropriately prevent generics and biosimilars from entering the market. Instead, the lack of generic competitors can be credited to their prospective return on investment being too small.
The report’s major findings are as follows:
- Adding an orphan indication to an on-market drug does not correlate with a higher than average price increase. The average price of therapies grew at a slower pace in 8 out of the 10 years following the addition of an orphan indication to the label.
- Of the 503 approved therapies with an orphan indication at the time the research was conducted, 217 are no longer covered by orphan exclusivity or patent protection. Of these 217 therapies, 116 of them have generic or biosimilar competition.
- The median spending on the 101 orphan drugs without protection from competition and without competitors is only $8.6 million per year per drug.
- Around one-quarter of orphan drug approvals target populations smaller than 5,000 patients in the United States.
- Since 2009, on-market common-disease drug prices have grown more every year, on average, than orphan drugs.
“The data shows that the seven-year market exclusivity provision is working as intended as an incentive for developing rare disease therapies and is not being abused,” said NORD’s President and CEO, Peter L. Saltonstall. “The NORD-sponsored study illustrates that the dilemma of rising drug prices in our country should not be attributed to orphan drugs. It is my hope that this report will provide empirical data necessary to make informed decisions.”
More than 7,000 rare diseases have been identified, affecting approximately 25-30 million Americans. Many affect only a few hundred or a few thousand individuals. Rare diseases tend to be chronic, serious and life-threatening. More than 80 percent are believed to be genetic.
Information on the report, including a link to the study, is available on the NORD website at www.rarediseases.org/rareinsights.
HIV Vaccine in Monkeys Suggests Human Vaccine on the Horizon
So far, a vaccine for HIV has been elusive. However, researchers with The Scripps Research Institute recently published positive data about its HIV vaccine in the journal Immunity that suggests one might be on the horizon.
A long way from human trials, the vaccine in rhesus macaque monkeys produced neutralizing antibodies against one strain of HIV that is similar to the most common strain. It also resulted in the first-ever estimate of what antibody levels would be needed to protect against HIV.
“We found that neutralizing antibodies that have been induced by vaccination can protect animals against viruses that look a lot like real-world HIV,” stated Dennis Burton, chair of Scripps Research’s Department of Immunology and Microbiology, and scientific director of the International AIDS Vaccine Initiative (AIVI) Neutralizing Antibody Center.
The trial offers proof-of-concept for Burton’s HIV vaccine strategy, which he and his colleagues have been working on since the 1990s. The strategy is to identify the vulnerable areas on HIV and then stimulate the immune system’s antibodies to attack those rare areas.
Research so far has indicated that the body must produce neutralizing antibodies that bind to the HIV’s outer envelope protein trimer. Burton and his team determined they could protect animals from HIV by injecting them with neutralizing antibodies produced in the lab.
They then needed to get the animals’ immune systems to make the neutralizing antibodies themselves. The researched exposed the animal immune systems to the envelope protein trimer, which basically trained their immune systems on how to identify, target and create the appropriate antibodies.
The key challenge was that the HIV envelope trimer is unstable and disintegrates when isolated. But in 2013, they genetically engineered a more stable trimer called SOSIP.
“For the first time, we had something that looked pretty much like the HIV envelope protein trimer,” stated Matthias Pauthner, a research associate at Scripps and co-first author of the study.
The new experimental vaccine contained the stable SOSIP trimer, which they tested in two groups of rhesus monkeys. Previous studies had shown that immunized monkeys naturally developed low neutralizing antibody levels, while others developed higher levels. So the team chose and re-vaccinated six monkeys who had previous low levels and six that previously had high levels. They had another 12 unimmunized monkeys as the control group.
The monkeys were then exposed to a strain of the virus called SHIV, an engineered simian version of HIV that has the same envelope trimer that’s found in the human virus.
The results were the vaccine worked in the animals with the high levels of antibodies. The animals produced high enough levels of neutralizing antibodies against the envelope protein trimer to prevent infection.
The researchers are working to develop broadly neutralizing antibodies (bnAbs) that can neutralize more strains of HIV instead of just the single strain used in the study.
Although the research marks significant work in identifying the neutralizing antibodies as vital in long-term immune protection, much more research needs to be done before the vaccine could be tested in humans and proof of long-term efficacy and safety is evaluated. “There are many immunological tricks that can be explored to make immunity last longer,” Pauthner stated.
Amgen, Molecular Partners Strategic Collaboration In Immuno-Oncology
Parties Will Jointly Develop MP0310, a Pre-clinical FAP x 4-1BB Multi-Specific DARPin® Molecule, in Combination with Amgen’s Oncology Assets, Including BiTE® Molecules
Molecular Partners Retains Rights to Develop MP0310 in Combination With its Pipeline Products
Amgen (NASDAQ:AMGN) and Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company pioneering the use of DARPin® therapeutics, today announced a collaboration and license agreement for the clinical development and commercialization of MP0310 (FAP x 4-1BB). MP0310 is a preclinical molecule designed to locally activate immune cells in the tumor by binding to FAP on tumor stromal cells (localizer) and co-stimulating T cells via 4-1BB (immune modulator).
Under the terms of the agreement, Amgen obtains exclusive global development and commercial rights for MP0310. The parties will jointly evaluate MP0310 in combination with Amgen`s oncology pipeline products, including its investigational BiTE® (bispecific T cell engager) molecules. Under the collaboration, Molecular Partners retains certain rights to develop and commercialize its proprietary DARPin® pipeline products in combination with MP0310.
Molecular Partners will receive an upfront payment of $50 million and is eligible to receive up to $497 million in development, regulatory and commercial milestone payments, as well as double-digit, tiered royalties up to the high teens. The parties will share the clinical development costs in defined percentages for the first three indications subject to certain conditions. For all additional clinical trials, Amgen is responsible for all development costs.
“MP0310 is the first candidate out of our portfolio of localized and multi-specific immune-cell agonists. This collaboration with Amgen will allow us to test multiple combinations of MP0310 with other agents, leveraging the potential of MP0310. We anticipate MP0310 to enter the clinic in 2019,” said Dr. Patrick Amstutz, chief executive officer of Molecular Partners. “The partnership with Amgen underlines the potential of MP0310 and the DARPin® platform to deliver novel therapeutic designs.”
“The field of immuno-oncology continues to rapidly evolve, and it’s our belief that combination treatments will have a major role to play in the future of cancer care,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “We look forward to collaborating with Molecular Partners to combine MP0310 with certain oncology assets, including BiTE® molecules, to deliver improved outcomes for patients.”
Conference call and audio webcast
Molecular Partners will host a conference call and audio webcast on Dec. 19, 2018, at 2 p.m. CET(1 p.m. GMT, 5 a.m. PT).
Molecular Partners will host a conference call and audio webcast on Dec. 19, 2018, at 2 p.m. CET(1 p.m. GMT, 5 a.m. PT).
In order to register for the conference call, please dial the following numbers approximately 10 minutes before the start of the presentation:
Switzerland / Europe
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+41 (0) 58 310 5000
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UK
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+44 (0) 207 107 0613
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USA
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+1 (1) 631 570 5613
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Interested parties can access a corresponding audio webcast of the presentation. The webcast will be accessible, both live and as a replay, on the investors section of the company’s website, along with the accompanying presentation slides.
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