Amgen To Acquire Five Prime Therapeutics For $1.9 Billion in Cash

  Amgen (NASDAQ: AMGN) and Five Prime Therapeutics (NASDAQ: FPRX), a clinical-stage biotechnology company focused on developing immuno-oncology and targeted cancer therapies, today announced an agreement under which Amgen will acquire Five Prime Therapeutics for $38.00 per share in cash, representing an equity value of approximately $1.9 billion. This acquisition adds Five Prime's innovative pipeline to Amgen's leading oncology portfolio.

• Five Prime's lead asset, bemarituzumab, is a first-in-class, Phase 3 ready anti-FGFR2b antibody with positive data from a randomized, placebo-controlled Phase 2 study in frontline advanced gastric or gastroesophageal junction (GEJ) cancer. Bemarituzumab targets FGFR2b, which has been found to be overexpressed in approximately 30% of patients with non-HER2 positive gastric cancer, as well as other solid tumors.
• The bemarituzumab Phase 2 FIGHT trial demonstrated clinically meaningful improvements in progression-free survival (PFS), overall survival (OS) and overall response rate (ORR) in the frontline treatment of patients with advanced gastric or GEJ cancer. Additional analysis showed a positive correlation between efficacy and expression of FGFR2b on tumor cells, confirming both the importance of the FGFR2b target and the activity of bemarituzumab against this target.
• This correlation suggests that FGFR2b could play a role in other epithelial cancers, including lung, breast, ovarian and other cancers. 
• The acquisition of Five Prime also supports Amgen's international expansion strategy. Gastric cancer is one of the world's most common forms of cancer and is particularly prevalent in the Asia-Pacific region, where Amgen expects to generate significant volume growth in the coming years. Amgen plans to leverage its presence in Japan and other Asia-Pacific markets to maximize bemarituzumab's potential. In addition, as part of this transaction, Amgen will receive a royalty percentage on future net sales in Greater China ranging from the high teens to the low twenties from a pre-existing co-development and commercialization agreement between Five Prime and Zai Lab (Shanghai) Co., Ltd.
• Five Prime's additional innovative pipeline programs complement Amgen's efforts to bring meaningful therapies to oncology patients. 

"The acquisition of Five Prime offers a compelling opportunity for Amgen to strengthen our oncology portfolio with a promising late-stage, first-in-class global asset to treat gastric cancer," said Robert A. Bradway, chairman and chief executive officer at Amgen. "We look forward to welcoming the Five Prime team to Amgen and working with them to leverage our best-in-class monoclonal antibody manufacturing capabilities to supply additional clinical materials, as well as expanded production quantities, to realize the full potential of bemarituzumab for even more patients around the world as quickly as possible."

"This is an exciting day for patients who may one day benefit from the promise of bemaritizumab and our full pipeline. I'm so proud of the Five Prime team and the science we've pioneered," said Tom Civik, president and chief executive officer of Five Prime. "We see tremendous complementarity between the two companies. Amgen has global reach, world-class resources, and they share our deep passion for science and commitment to patients.  I have full confidence that Amgen is the right company to work with us to bring our innovative cancer treatments to patients and to achieve our mission to rewrite cancer." 

Transaction Terms
Under the terms of the merger agreement, which was approved by the Boards of Directors of both companies, Amgen will commence a tender offer to acquire all of the outstanding shares of Five Prime's common stock for $38.00 per share in cash. Following the completion of the tender offer, a wholly-owned subsidiary of Amgen will merge with Five Prime and shares of Five Prime that have not been tendered and purchased in the tender offer will be converted into the right to receive the same price per share in cash as paid in the tender offer (other than shares held by stockholders who properly demand and perfect appraisal rights under Delaware law).

The transaction is expected to close by the end of the second quarter and is subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of Five Prime's common stock and the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

Amgen reaffirmed its full-year outlook with Revenue guidance of $25.8 to $26.6 billion and non-GAAP EPS guidance of $16.00-$17.00.

Goldman Sachs acted as financial advisor to Amgen and Sullivan & Cromwell LLP as its legal advisor. Lazard acted as financial advisor to Five Prime and Cooley LLP as its legal advisor.

Amgen Webcast Investor Call
Amgen will host a webcast call for the investment community on Thursday, March 4, 2021, at 10:30 a.m. EST. Peter H. Griffith, executive vice president and chief financial officer, David M. Reese, M.D., executive vice president of Research and Development, and Murdo Gordon, executive vice president of Global Commercial Operations at Amgen will participate. 

Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public. The webcast, as with other selected presentations regarding developments in Amgen's business given at certain investor and medical conferences, can be accessed on Amgen's website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event. 

https://www.biospace.com/article/releases/amgen-to-acquire-five-prime-therapeutics-for-1-9-billion-in-cash/

Becton Dickinson Buys Medication-Storage Company GSL Solutions

 Becton, Dickinson and Co. has acquired GSL Solutions Inc., a privately held company that makes devices to securely store medication.

The addition of GSL, headquartered in Vancouver, Wash., will expand Becton Dickinson's offerings to retail pharmacies, with storage that facilities can use to store controlled substances and comply with relevant regulations. GSL makes computerized lockers and cabinets that restrict access to controlled substances and automatically log user activity to comply with laws and regulations.

Franklin Lakes, N.J.-based Becton Dickinson didn't disclose the terms of the deal.

GSL has about 20 full-time employees, Becton Dickinson said.

https://www.marketscreener.com/quote/stock/BECTON-DICKINSON-AND-COM-11801/news/Becton-Dickinson-and-nbsp-Buys-Medication-Storage-Company-GSL-Solutions-32603965/

Europe starts formal review of Russia's Sputnik V COVID-19 vaccine

 Europe’s medicines regulator said on Thursday it had started a rolling review of Russia’s Sputnik V COVID-19 vaccine, an important display of confidence in the shot that paves the way for its potential approval across the 27-nation bloc.

Hungary became the first EU country to grant the Russian vaccine emergency national approval in January, Slovakia has ordered shipments, and Czech Prime Minister Andrej Babis has said his country could move to use Sputnik V.

The European Medicines Agency (EMA) said in a statement it would review data from ongoing trials of the vaccine until there was enough evidence for a formal marketing authorisation application. (bit.ly/3uQxwfL)

EMA’s ‘rolling reviews’ are aimed at speeding up the approval process by allowing researchers to submit findings in real-time before final trial data is ready.

“While EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review,” it said.

Kirill Dmitriev, CEO of the RDIF sovereign wealth fund that is promoting Sputnik V internationally, hailed the start of EMA’s rolling review as an important moment for Russia which he said showed its application had been a strong one.

“Sputnik V can act as a bridge between Russia and Europe, but its roll out should not get bogged down in politics,” Dmitriev told Reuters, praising Germany, France, Italy and Austria for what he called their pragmatic approach to Sputnik V.

The shot’s efficacy was initially greeted with scepticism by some Western scientists after Russia approved it in August last year without waiting for the results of full clinical trials.

However, some of those initial concerns appear to have faded after scientists said it was almost 92% effective in fighting COVID-19, based on peer-reviewed late-stage trial results published in The Lancet medical journal last month.

The two-shot vaccine uses two different weakened common cold viruses to deliver immune-building protein to the human body.

Dmitriev said Moscow could provide vaccines for 50 million Europeans starting from June if the shot won EU-wide approval, adding he expected several EU countries to approve the use of Sputnik V this month for their national use.

He did not name the countries.

Europe has so far approved vaccines from Pfizer/BioNTech, Moderna and AstraZeneca/Oxford, while ongoing reviews for CureVac and Novavax’s candidates are underway.

The EMA is expected to give its verdict on J&J’s single-shot vaccine on March 11.

https://www.reuters.com/article/us-health-coronavirus-europe-vaccines/europe-starts-formal-review-of-russias-sputnik-v-covid-19-vaccine-idUSKCN2AW0W8

Oncocyte expands access to DetermaRx

 Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, has signed an agreement with MultiPlan to participate in its networks. Through this agreement DetermaRx™ will now be available to those consumers with access to the PHCS and MultiPlan Network, MultiPlan’s national primary and complementary networks, at a pre-negotiated price per test. With more than one million healthcare providers participating in these networks and 60 million health plan members having access to MultiPlan’s services, this agreement significantly broadens the accessibility of Oncocyte’s proprietary treatment stratification test that identifies lung cancer patients with early stage non-squamous NSCLC who may benefit from adjuvant chemotherapy.

“Our agreement with MultiPlan underscores the recognition by the healthcare community of the important role DetermaRx plays in identifying lung cancer patients who are at high risk of recurrence, and whose survival rates can greatly benefit from receiving timely treatment,” said Padma Sundar, Chief Commercial Officer of Oncocyte. “MultiPlan’s partnership with hundreds of healthcare payors, along with its vast group of providers and plan members, will enable significantly expanded access to DetermaRx.”

https://www.globenewswire.com/news-release/2021/03/04/2187085/0/en/Oncocyte-Announces-Agreement-with-MultiPlan-Network-Expanding-Patient-Access-to-DetermaRx.html

Lipocine Publishes on Potential of LPCN 1144 in NASH, Hepatic Fibrosis

 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced the publication of preclinical results supporting the therapeutic potential of LPCN 1144 in the treatment of and non-alcoholic steatohepatitis ("NASH") and hepatic fibrosis. The results were featured in a paper entitled "Treatment Potential of LPCN 1144 on Liver Health and Metabolic Regulation in a Non–Genomic, High Fat Diet Induced NASH Rabbit Model" (Comeglio et al), published in the Journal of Endocrinological Investigation (https://doi.org/10.1007/s40618-021-01522-7).

https://www.prnewswire.com/news-releases/lipocine-announces-publication-in-journal-of-endocrinological-investigation-highlighting-the-potential-of-lpcn-1144-in-the-treatment-of-nash-and-hepatic-fibrosis-301240212.html

Soligenix: Positive Progress in Pre-clinical Development of COVID-19 Vaccine

  Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today publication of pre-clinical immunogenicity studies for CiVax™ (heat stable COVID-19 vaccine program) demonstrating rapid-onset, broad-spectrum, neutralizing antibody and cell-mediated immunity is confirmed using full-length Spike protein antigens. The article titled, "Recombinant protein subunit SARS-CoV-2 vaccines formulated with CoVaccine HT adjuvant induce broad, Th1 biased, humoral and cellular immune responses in mice," has been posted as an accelerated preprint on bioRxiv (available here). This work will continue under a $1.5M Small Business Innovation Research (SBIR) grant awarded to Soligenix in December 2020.

CiVax™ is the Company's heat stable subunit vaccine candidate for the prevention of COVID-19, the infection caused by SARS-CoV-2. Ongoing collaborations with Axel Lehrer, PhD, Associate Professor in the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), University of Hawaiʻi at Mānoa, have confirmed the feasibility of developing a broadly immunogenic vaccine for COVID-19. Using an efficient expression system in Drosophila S2 cells developed by Hawaii Biotech Inc., full-length Spike protein antigens have been produced and tested for immunogenicity in this latest work. These latest results demonstrate the immunogenic potential of the full-length CiVax™ antigen in combination with CoVaccine HT™, specifically in the context of SARS-CoV-2.

While a number of vaccines are available worldwide under Emergency Use Authorization, the requirement for cold chain shipping and timely administration, coupled with manufacturing scale up logistics, have limited the world's supply. Rapid vaccine administration worldwide is necessary to curtail disease spread and slow or pre-empt evolution of mutations, which may abrogate the effectiveness of current vaccine approaches. Previous work with the novel CoVaccine HT™ adjuvant, which Soligenix licensed from BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation, has indicated that CoVaccine HT™ can be thermostabilized both alone and in combination with antigens, potentially yielding a single vial presentation of the vaccine, which would not require cold chain distribution or storage.   

https://www.biospace.com/article/releases/soligenix-announces-positive-progress-in-the-pre-clinical-development-of-its-covid-19-vaccine/

Arbutus 2020 earnings, corporate update

AB-729, Arbutus’ proprietary subcutaneously delivered RNAi agent, demonstrates robust and continuous declines in hepatitis B surface antigen (HBsAg) in subjects with chronic hepatitis B (HBV) with favorable safety and tolerability data

Reductions in HBsAg seen in both HBV DNA negative and HBV DNA positive subjects support a potential dosing schedule for AB-729 as infrequently as every 8 to 12 weeks

Several AB-729 Phase 2 proof-of-concept combination clinical trials expected to initiate this year

AB-836, Arbutus’ proprietary oral capsid inhibitor, on track to begin a Phase 1a/1b clinical trial in healthy volunteers and subjects with HBV in the first half of 2021

Conference Call and Webcast Scheduled Today at 8:45 AM ET

Arbutus will hold a conference call and webcast today, Thursday, March 4, 2021 at 8:45 AM Eastern Time to provide a corporate update. You can access a live webcast of the call, which will include presentation slides, through the Investors section of Arbutus’ website at http://www.arbutusbio.com or directly at Live Webcast. Alternatively, you can dial (866) 393-1607 or (914) 495-8556 and reference conference ID 4084504.

An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling (855) 859-2056 or (404) 537-3406, and reference conference ID 4084504.

https://www.globenewswire.com/news-release/2021/03/04/2187007/0/en/Arbutus-Reports-Fourth-Quarter-and-Year-End-2020-Financial-Results-and-Provides-Corporate-Update.html