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Thursday, January 3, 2019

Verastem aims to continue expanding commercial traction of copiktra


Verastem highlighted the company’s recent progress and outlined strategic priorities for 2019. “2018 was a pivotal year for Verastem Oncology, as the U.S. Food and Drug Administration’s approval of COPIKTRA and other key accomplishments strongly positioned us to execute on our 2019 corporate priorities that are focused on increasing revenues, initiating additional clinical studies of COPIKTRA and advancing our pipeline,” said Robert Forrester, President and Chief Executive Officer of Verastem Oncology. “We are pleased with the strong vote of confidence we have received in duvelisib, including validating licensing agreements in key Asian markets, recognition of our pivotal Phase 3 data in the medical journal Blood, and more. We are also entering 2019 with a strong balance sheet derived from the successful completion of multiple financing transactions, which we believe provides us with important financial strength to achieve our planned corporate objectives. We look forward to keeping the momentum going, and to sharing ongoing updates on our progress.” Verastem Oncology’s 2019 focus is to execute on business priorities aimed at increasing the company’s sales and revenues: Continuing to expand on the commercial traction of COPIKTRA in CLL/SLL and FL for appropriate patients; Expansion of the open-label, multicenter, Phase 2 clinical trial evaluating the efficacy and safety of duvelisib monotherapy in adult patients with histologically confirmed relapsed or refractory PTCL. This study is expected to enroll approximately 120 patients; Initiating a confirmatory Phase 3 study evaluating duvelisib for the treatment of patients with relapsed or refractory FL after at least two prior systemic therapies. The confirmatory study is expected to start in the second half of 2019; Initiating additional investigational studies of duvelisib as a monotherapy and in combination with other anti-cancer agents, such as checkpoint inhibitors, in both hematological and solid tumor malignancies; Working with the LLS to advance the PTCL program including the expansion of the Phase 2 combination study of duvelisib and romidepsin for patients with relapsed or refractory PTCL; Additional ex-U.S. partnerships for duvelisib; Presenting and publishing additional duvelisib data; and advancing the company’s focal adhesion kinase inhibitor defactinib, which is designed to treat cancer through modulation of the tumor microenvironment and enhancement of anti-tumor immunity. Defactinib is currently being evaluated in three separate clinical collaborations in combination with immunotherapeutic agents for the treatment of several different cancer types including pancreatic cancer, non-small cell lung cancer, and mesothelioma.
https://thefly.com/landingPageNews.php?id=2843453

Flexion CEO comments first full year launch of Zilretta


“2018 was a foundational year for ZILRETTA, and in the first full year of the launch, we saw strong product uptake as we established a broad and growing base of prescribers. Furthermore, the clinical feedback on ZILRETTA from physicians and patients alike continues to be overwhelmingly positive and gratifying,” said Michael Clayman, M.D., President and Chief Executive Officer. “We now enter 2019 with a product-specific J code, which we believe will be a key driver of continued ramp, as it provides prescribers with a well-known and clearly defined reimbursement mechanism that is utilized by both Medicare and private payers. Each year, roughly five million people in the U.S. receive intra-articular injections for osteoarthritis knee pain, and we believe ZILRETTA will play an increasingly significant role in the treatment paradigm for this large and growing patient population.”
https://thefly.com/landingPageNews.php?id=2843455

Regenxbio provides corporate update on candidate development programs


Regenxbio (RGNX) provided a year-end 2018 corporate update. Highlights include: further positive interim update from RGX-314 Phase I trial for wet AMD, in which 50% of subjects treated in Cohort 3 continue to remain free of anti-VEGF injections at nine months and mean RGX-314 intraocular protein expression in recently dosed Cohort 4 was higher than in previously reported Cohort 3 at one month; received FDA clearance to expand RGX-314 Phase I protocol immediately into a Phase IIa clinical trial, and on track to initiate Phase IIb trial in late 2019; plans to expand RGX-314 into additional retinal conditions, with the first such IND submission anticipated in 2H19; RGX-121 was well-tolerated in first patient dosed at initial eight-week safety assessment; additional recruitment and site activation continues; interim trial updates for RGX-121, RGX-111 and RGX-501 anticipated in 2H19; first anticipated FDA regulatory action for a proprietary NAV Technology-based treatment, Novartis’ (NVS) Zolgensma for the treatment of SMA Type I, expected in May; the company had over $470M in cash, cash equivalents and marketable securities as of December 31, 2018, and expects to end 2019 with over $330M in cash, cash equivalents and marketable securities, excluding any projected commercial revenue from Zolgensma.
https://thefly.com/landingPageNews.php?id=2843459

Celgene upgraded to Neutral from Sell at Goldman Sachs


Goldman Sachs analyst Terence Flynn upgraded Celgene (CELG) to Neutral and raised his price target for the shares to $88 from $71 after the company entered into a definitive agreement to be acquired by Bristol-Myers Squibb (BMY). While the analyst still sees execution risk on Celgene’s pipeline, he now expects the shares to move on M&A potential. He sees a balanced risk/reward relative to his new price target. Flynn takes no view on the likelihood of the proposed merger closing.
https://thefly.com/landingPageNews.php?id=2843495

Corbus to collaborate with Kaken to commercialize Lenabasum in Japan


Corbus Pharmaceuticals announced that they have entered into a strategic collaboration with Kaken Pharmaceutical Co. for the development and commercialization in Japan of Corbus’ investigational drug lenabasum for the treatment of systemic sclerosis and dermatomyositis, two rare and serious autoimmune diseases. Under the terms of the agreement, Kaken receives an exclusive license to commercialize and market lenabasum in Japan for systemic sclerosis and dermatomyositis. Kaken will make an upfront payment to Corbus of $27M. Corbus will be eligible to receive in addition up to $173M upon achievement of certain regulatory, development and sales milestones as well as double-digit royalties. Current patient numbers for systemic sclerosis and dermatomyositis1 in Japan are 28,000 and 9,000, respectively, according to the companies. Yuval Cohen, PhD., CEO of Corbus, said, “Kaken is a well-regarded leader in rare autoimmune diseases in Japan with a proud history of scientific and medical innovation. By working together, we believe we can expand the Japanese footprint for lenabasum alongside Corbus’ ongoing efforts in the U.S. and E.U. This collaboration is an important next step in achieving our vision of becoming the global leader in treating inflammatory diseases by focusing on the endocannabinoid system.”

Green Growth reaffirms commitment to takeover Aphria


GREEN GROWTH REAFFIRMS COMMITMENT TO ACQUIRE APHRIA:  On Monday, Green Growth Brands reaffirmed its commitment to launch an offer to purchase all shares of Aphria . “Since we announced our intention to launch the takeover of Aphria we have seen two things. First, Aphria shareholders are welcoming a 45%+ premium offer because they understand the significant value that can be unleashed by our combined teams, assets and geographies. Second, a real interest in the market to understand Green Growth and our valuation,” Green Growth chief executive officer Peter Horvath said. “When investors consider our trailing revenue, recent license wins in Nevada, and a buildout in the new market of Massachusetts they agree that it is not a question of if Green Growth reaches C$7.00 per share, but when. We understand that there are some in the market who want to focus on destroying value at Aphria, but we are committed to creating it.” The company said it is “confident in the certainty of a C$300M financing at C$7.00 per share. Over 10% of Aphria’s shareholders have already indicated their support of the offer.” It added that “Aphria’s board has two options: Engage with Green Growth as a serious buyer to create real value or continue their endless analysis which will result in the destruction of shareholder value.”

Alexion, Biogen seen as potential targets after Celgene buyout


Shares of Celgene (CELG) are on the rise after the company announced that it has agreed to be acquired by Bristol-Myers Squibb (BMY) in a cash and stock transaction with an equity value of about $74B, or $102.43 a share. Commenting on the news, Piper Jaffray analyst Christopher Raymond told investors that the deal is a “big positive” for the sector and argued that Alexion Pharmaceuticals (ALXN) and Biogen (BIIB) would seem to make sense as potential targets among large-caps.
BRISTOL-MYERS TO BUY CELGENE: Bristol-Myers Squibb and Celgene announced that they have entered into a definitive merger agreement under which the former will acquire the latter in a cash and stock transaction with an equity value of approximately $74B. Under the terms of the agreement, Celgene shareholders will receive 1.0 Bristol-Myers Squibb share and $50 in cash for each share of Celgene. Celgene shareholders will also receive one tradeable Contingent Value Right for each share of Celgene, which will entitle the holder to receive a payment for the achievement of future regulatory milestones. The Boards of Directors of both companies have approved the combination. Based on the closing price of Bristol-Myers Squibb stock of $52.43 on January 2, 2019, the cash and stock consideration to be received by Celgene shareholders at closing is valued at $102.43 per Celgene share and one CVR. When completed, Bristol-Myers Squibb shareholders are expected to own approximately 69% of the company, and Celgene shareholders are expected to own approximately 31%. The combined company will have nine products with more than $1B in annual sales. Giovanni Caforio, Chairman and CEO of Bristol-Myers Squibb, will continue to serve as Chairman of the Board and CEO of the company when the transaction closes. Two members from Celgene’s Board will be added to the Board of Directors of Bristol-Myers Squibb. Bristol-Myers Squibb and Celgene expect to complete the transaction in the third quarter of 2019.
ALEXION, BIOGEN COULD BE NEXT: In a research note following the news, Piper Jaffray’s Raymond told investors that he remains “bullish on biotech” and that he views Celgene’s acquisition as a “big positive” for the sector. While he acknowledged that Celgene has its challenges with about 64% of its revenue facing generic entry beginning in 2022, he argued that “this is clearly positive” to the sector in that it reminds investors of upside potential in the space. When large-cap biotechs find themselves under duress, more often than not the exit is a take-out and the announced acquisition in light of Celgene’s recent history of clinical, regulatory, and operational setbacks and subsequent share price decline certainly fits this pattern, Raymond noted. The analyst believes the market is likely to ask “who’s next?” Among large-caps, Alexion Pharmaceuticals and Biogen would seem to make sense as potential targets, Raymond said, adding that BioMarin Pharmaceutical (BMRN) could also be a perennial takeout candidate as an immediate bolt-on rare disease business for any strategic buyer. While any small to mid cap could likely be seen as a take-out candidate, the analyst believes Aimmune Therapeutics (AIMT), Deciphera Pharmaceuticals (DCPH) and Rigel Pharmaceuticals (RIGL) in particular “could make sense to any strategic buyer” as all three have assets with clearly defined clinical profiles that could “fit nicely” within established commercial infrastructures.
CELGENE BUYOUT POSITIVE FOR FATE: In a research note of his own, Piper Jaffray analyst Edward Tenthoff told investors that he believes Bristol-Myers Squibb’s agreement to acquire Celgene is in part driven by the long-term potential of cellular therapies to treat cancer. As such, the analyst argued that the deal is a positive for Fate Therapeutics (FATE), which he noted is developing a pipeline of allogeneic and induced pluripotent stem cell natural killer and T-cell therapies. Fate is a potential acquisition target for its “rich cell therapy pipeline and platform,” Tenthoff contended, adding that it remains a top pick for 2019. He reiterated an Overweight rating and a $23 price target on Fate’s shares.