Merck and Instituto Butantan, Sao Paulo, Brazil announced a collaboration agreement to develop vaccines to protect against dengue virus disease, the mosquito-borne infection. Instituto Butantan and Merck have licensed certain rights from National Institute of Allergy and Infectious Diseases, part of the United States National Institutes of Health, for the development of live attenuated tetravalent vaccines. Instituto Butantan’s dengue vaccine candidate, TV003, is currently being evaluated in a large Phase 3 study in Brazil. Under the agreement, Merck and Instituto Butantan have agreed to collaborate to share clinical data and other learnings from their respective dengue vaccine development programs, both derived from licensed materials from the NIAID. Instituto Butantan will receive a $26M upfront payment from Merck and is eligible to receive up to $75M for the achievement of certain milestones related to the development and commercialization of Merck’s investigational vaccine as well as potential royalties on sales. Instituto Butantan will retain responsibility for the manufacturing and commercialization of their investigational vaccine, TV003, in Brazil. The agreement builds upon a productive long-term collaboration between MSD Brazil and Instituto Butantan, initiated in 2012, for human papillomavirus and Hepatitis-A vaccine products.
Wednesday, December 12, 2018
Mallinckrodt rises despite FDA failing to approve opioid painkiller
Shares of Mallinckrodt (MNK) dropped in morning trading, but have recovered and turned positive in an up day for the broader market, after the Food and Drug Administration declined to approve a reformulated version of the drug maker’s opioid painkiller Roxicodone. The new version was designed to deter opioid abuse.
COMPLETE RESPONSE LETTER: On Wednesday, Mallinckrodt said that its SpecGx LLC subsidiary received a Complete Response Letter from the U.S. Food and Drug Administration regarding its new drug application for Roxicodone, a treatment for pain that is severe enough to require an opioid. The letter provides guidance on areas of further evaluation needed to resubmit the NDA for further review and possible approval of the drug, which was designed with properties to deter intravenous and intranasal abuse under the company’s 505(b)(2) new drug application for MNK-812, the company said. Matt Harbaugh, the company’s president, Specialty Generics, said in a statement that “We are evaluating the FDA’s letter and will request a meeting in the coming weeks to discuss it further. We continue to believe this new abuse-deterrent formulation has the potential to mitigate opioid abuse and misuse, and though we’re disappointed by the FDA’s decision, we will continue to pursue a pathway to try to gain approval of the drug.” Mallinckrodt is planning to spin off its specialty generics business to shareholders by the second half of 2019, but said it was still open to a sale of the unit, it said last week.
WHAT’S NOTABLE: Roxicodone is an abuse-deterrent, immediate-release formulation that the company is developing as part of an effort to curb the current opioid addiction crisis in the U.S. The FDA’s decision comes after an advisory panel last month voted 10-7 in favor of the drug. The committee also voted 12-5 that the drug should be labeled abuse-deterrent by the nasal route of abuse and 10-7 that it should not be labeled abuse-deterrent by the intravenous route of abuse. At the time, a panel member who voted in favor of the drug’s approval said that “While all the abuse deterrent properties of this medication are perhaps not as robust as we might like, it is an important advance over the existing formulation.” In June 2017, Endo International’s (ENDP) reformulated Opana ER was withdrawn from the market after data showed that while rates of nasal abuse associated with Opana fell, rates of intravenous abuse rose. Mallinckrodt, Endo and others including Johnson & Johnson (JNJ) have been sued by local and state government who claim the companies have contributed to the national epidemic through their marketing and promotion of opioids.
Piper Jaffray reiterates Overweight on Aveo after AstraZeneca partnership
Piper Jaffray reiterates Overweight on Aveo after AstraZeneca partnership. Piper Jaffray analyst Edward reiterated an Overweight rating and $5 price target on Aveo Oncology (AVEO), after the company announced a partnership with AstraZeneca (AZN) to conduct a Phase I/II study of durvalumab + tivozanib in in first-line liver cancer. The analyst also noted that, following positive Phase III TIVO-3 data in 3rd+ line RCC for tivozanib, Aveo intends to file an NDA in the first half of 2019 with mature OS data likely in Q3 of 2019. Tenthoff expects FDA approval and launch in 2020 forecasting U.S. sales of $32M in 2020 growing to $218M in 2025.
Bausch buy of Synergy ‘inconsequential financial deal,’ says Wells Fargo
After Bausch Health (BHC) announced plans to acquire certain assets of Synergy Pharmaceuticals (SGYP), which makes irritable bowel syndrome drug Trulance, Wells Fargo analyst David Maris called the acquisition “an inconsequential financial deal that points to a bigger picture of [Bausch] returning to its cost-cutting deal roots and a potential lack of confidence in growth of the core business.” He views the $700M of added market value for Bausch in return for a $200M deal as unjustified and probably reflective of short-covering, Maris added. He maintains an Underperform rating and $9 price target on Bausch Health shares.
Narcan competitor price cut ‘worth watching closely,’ says Wells Fargo
After privately-held Kaleo announced plans to offer an
authorized generic of its naloxone HCI auto injector product for a list
price of $178 per carton, Wells Fargo analyst David Maris noted that
when Emergent BioSolutions purchased Adapt Pharma and its naloxone-based
Narcan the company had said that it expected Narcan to generate
$200M-$220M in revenues in 2019. Emergent also said at the time of the
deal that it expected additional competition, says Maris, who believes
“this pricing move is worth watching closely.” The analyst also pointed
out that next week the FDA is hosting a meeting to discuss ways to
increase the availability of naloxone, including co-prescriptions, which
would be a potential positive for Emergent, and OTC availability, which
is a possible negative. Maris keeps a Market Perform rating on Emergent
BioSolutions shares.
https://thefly.com/landingPageNews.php?id=2836217
Foamix initiated at BofA/Merrill
Foamix initiated with a Buy at BofA/Merrill. BofA/Merrill analyst Jason Gerberry initiated Foamix with a Buy and $11 price target citing de-risked dermatology assets. Gerberry said Foamix offers two late-stage drugs with efficacy that are competitive to existing therapies but offer a topical alternative to widely used oral minocycline, with less safety baggage as a systemically absorbed drug. The analyst thinks FMX-101 and -103 will take market share and build recognition in the “experience-driven derm space.”
https://thefly.com/landingPageNews.php?id=2835769
https://thefly.com/landingPageNews.php?id=2835769
Corcept Therapeutics upgraded to Overweight from Neutral at Cantor Fitzgerald
https://thefly.com/landingPageNews.php?id=2835773
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