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Thursday, September 20, 2018

Molecular Templates, Takeda in Multiple Myeloma in Deal Worth up to $632M


Shares of Molecular Templates are up more than 52 percent in premarket trading after the company announced it has struck a deal with pharma giant Takeda Pharmaceuticalthat could be worth up to $632 million to develop CD38-targeted engineered toxin bodies (ETBs).
This morning Austin, Texas-based Molecular Template said the companies will jointly develop the lead CD38-targeted engineered toxin body to target multiple myeloma. The two companies initially plan to collaborate on a CD38-targeted ETB that resulted from a previous discovery collaboration between the two companies. In an announcement late Wednesday, the two companies said they developed preclinical stage ETBs targeting CD38 under the prior discovery collaboration.
Eric Poma, chief executive and chief scientific officer at Molecular Template, said the two companies have worked closely since 2016 to develop CD38-targeted ETBs. During that time, Poma said they have made substantial improvements over its own internal program, MT-4019, a CD38 targeted ETB for multiple myeloma. Earlier this year the company said it intended to take MT-4019 into Phase I development by the end of the third quarter.
Multiple myeloma is an incurable cancer found in bone marrow. There are more than 118,000 people living with, or in remission from, multiple myeloma in the United States. Approximately 30,280 Americans are diagnosed with multiple myeloma each year and 12,590 patient deaths are reported on an annual basis, according to the American Cancer Society.
Multiple myeloma cells widely express the CD38 protein, making it an increasingly important target in the development of therapeutics for multiple myeloma. There are already some CD38-targeted treatments for multiple myeloma on the market, including Janssen’s Darzalex.
By targeting the CD38 protein with ETBs, they can deliver a modified bacterial toxin to the myeloma cells. That toxin destroys the cancer cells through the enzymatic and irreversible destruction of ribosomes, the companies said. Unlike other CD38-targeted therapies, ETBs are not reliant on the body’s own immune system for effectiveness, offering the potential of broader and deeper responses, Takeda and Molecular Templates said in a statement.
“Takeda’s expertise in multiple myeloma and strong antibody capabilities allowed us to develop CD38-targeted ETBs that, of the ones tested to date, are the most potent ETBs we have created with our platform.  We look forward to moving this program into the clinic,” Poma said in a statement.
Philip Rowlands, Takeda’s head of the Oncology Therapeutic Area Unit, pointed to Takeda’s long commitment to developing blood cancer treatments. As Takeda has worked with Molecular Templates over the past two years, Rowlands said they have “seen the promise” of Molecular’s ETB platform.
“As we expand our relationship and continue to explore next-generation modalities, our hope is to bring forth new and important treatment options for patients,” Rowland said in a statement.
Under terms of the agreement, Molecular Templates will receive $30 million from Takeda as part of an upfront payment. Molecular Templates is eligible to receive development, regulatory and commercial milestone payments of up to $632.5 million if Molecular Templates exercises its co-development option or $337.5 million if Molecular Templates does not exercise or opts out of its co-development option. Takeda has also agreed to pay royalties on sales of the commercial product developed through the collaboration. Molecular Templates and Takeda will share equally in the development costs.

Lilly has been ‘very clear’ on plans to exit Elanco stake in 2019, Simmons says


Elanco (ELAN) CEO Jeff Simmons is being interviewed on CNBC. Eli Lilly (LLY) is spinning off Elanco via an IPO this morning.
https://thefly.com/landingPageNews.php?id=2793275

New Age Beverages to Debut CBD Product Portfolio at Convenience Store Confab


NEW AGE BEVERAGES CORPORATION (NASDAQ: NBEV), the Colorado-based organic and natural healthy functional beverage company intending to become the world’s leading healthy beverage company, today announced that it intends to debut its portfolio of CBD infused beverages at the upcoming North American Convenience Store show (NACS) to be held at the Las Vegas Convention Center on October 7-10, 2018.
Given the growing awareness of the potential health benefits of CBD, the New Age Health Sciences Division evaluated the data and science supporting the emerging segment. As a result of that assessment, New Age began testing a CBD-infused beverage earlier this year in its home market in Colorado. Based on the learnings gained in the test market and the increased consumer acceptance of the segment, New Age has decided to expand its presence in the category. The Company has taken the learnings it gained in product formulation and taste, efficacy and dosage, and consumer communication and has developed a portfolio of CBD-infused beverages. Now, coupled with the increased interest from major retailers in North America, New Age intends to unveil its portfolio and category insights with select retail partners at the NACS show on October 8th.
According to the Brightfield Group, the Global market for CBD will top $22 Billion with the next 4 years. Non-psychotropic CBD is one of the most medicinal compounds in the cannabis plant, reportedly helping with everything from arthritis to epilepsy and cancer, and is seen by many as a natural remedy instead of a pharmaceutical or narcotic drug. The 2018 Farm Bill, which was recently passed by both the House and Senate, would likely legalize CBD for farmers across the country and allow it for sale nationally in all channels.
New Age will be meeting with some of the major retailers in the country at NACS on October 8-10th and taking orders on a first come, first serve basis, given anticipated demand. New Age’s Health Sciences Division is overseeing and carefully controlling production, quality, and its supply chain and sales channel partners given the importance of efficacy and quality control in the end product.
Zach Ross, Marley Marketing Manager at New Age commented, “We believe we have developed unique consumer insights and accessed superior technology in CBD-infused beverages over the past year, and we are excited to share those insights with key retail partners. We believe we are in a position to bring national leadership to this emerging growth segment, and intend to launch the most efficacious and safe CBD-infused products for consumers, with the most responsible marketing and education to a segment that has potential to be transformative to healthy functional beverages.”

Walgreens Boots Alliance announces launch of flagship store on Alibaba Tmall


Walgreens Boots Alliance (WBA) and Alibaba Group (BABA) announced the launch of a Boots flagship store on Tmall Global, Alibaba’s B2C platform for international brands and retailers, to introduce a number of iconic Boots beauty brands to more than half a billion consumers on Alibaba’s platforms in China. The new Boots flagship Tmall Global store gives Chinese consumers access to some of the most popular Boots beauty brands in the UK and the U.S., initially No7, Soap & Glory and Boots Cucumber, reflecting the Chinese consumers’ increasing sophistication and appetite for high-quality, international beauty brands.

Mylan, Fujifilm Kyowa get Euro Authorization for Humira biosimilar


Mylan (MYL) and Fujifilm Kyowa Kirin Biologics announced that the European Commission has granted marketing authorization for Hulio, a biosimilar to AbbVie’s (ABBV) Humira – adalimumab -, for all indications. The authorization follows the adoption of a positive opinion by the Committee for Medicinal Products for Human Use, which concluded that the development program including analytical, functional, clinical and immunogenicity data demonstrated biosimilarity with the reference product, Humira. The EC approval of Hulio applies to all 28 European Union member countries and European Economic Area member states of Norway, Iceland and Liechtenstein. Mylan plans to launch Hulio across various markets in Europe on or after Oct. 16. Mylan and Fujifilm Kyowa Kirin Biologics partnered earlier this year. Fujifilm Kyowa Kirin Biologics has a nonexclusive royalty bearing license with AbbVie for the use and sale of Hulio in European countries. Humira had brand sales of approximately $4.4B in Europe for the 12 months ending June 30, 2018.

Buy Tandem Diabetes on recent weakness, says Oppenheimer


Oppenheimer analyst Steve Lichtman tells investors in a research note that he is a buyer of Tandem Diabetes (TNDM) shares on recent weakness and ahead of its September 25 Investor & Analyst Day. Lichtman says Tandem will bring the next advanced insulin pumps to market beyond Medtronic (MDT) with Basal-IQ rolling out now and Control-IQ in summer 2019, which position Tandem well to be a share gainer.

Merrimack receives $5M milestone payment from Shire


Merrimack (MACK) has received a $5M milestone payment from Shire (SHPG), triggered by the sale of Onivyde in the first major non-European, non-Asian country, pursuant to the terms of Merrimack’s asset sale to Ipsen in 2017. The terms of the company’s asset sale to Ipsen in 2017 entitled Merrimack to receive up to an aggregate of $33.0M in net milestone payments from Shire, of which Merrimack has now received $23.0M, including this milestone and the $18.0M payment in August 2018 resulting from the sale of Onivyde in two additional major European countries. Merrimack remains eligible to receive up to an additional $10.0M in milestone payments for the first patient dosed in a pivotal clinical trial of Onivyde in an indication other than pancreatic cancer. Furthermore, Merrimack is entitled to receive up to an aggregate of $450M in regulatory-based milestones from Ipsen. Merrimack expects to pass these proceeds through to stockholders, net of any taxes owed and subject to there being a sufficient surplus at that time, consisting of: $225.0M upon approval by the FDA of Onivyde for the first-line treatment of metastatic adenocarcinoma of the pancreas, subject to certain conditions; $150.0M upon approval by the FDA of Onivyde for the treatment of small cell lung cancer after failure of first-line chemotherapy; and $75.0M upon approval by the FDA of Onivyde for an additional unrelated indication.