Bristol-Celgene Big Winner? Los Angeles Billionaire Patrick Soon-Shiong

While billionaire M.D. Patrick Soon-Shiong’s flashy purchases of the Los Angeles Times newspaper or investments in video-gaming companies have more recently made headlines, it’s his longtime estimated stake in biopharma giant Celgene CELG +5.57% that helped push his net worth up at least $194 million on Thursday on a day when many other billionaires’ fortunes took a dive.

At market close, Celgene shares were up nearly 14% following Bristol-Myers Squibb BMY +3.92%’s Thursday announcement that it would pay $74 billion in cash and stock for the company. Soon-Shiong is now worth an estimated $6.9 billion according to Forbes real-time rankings of the world’s billionaires. As Forbes reported, Bristol will give one of its own shares plus $50 for each share of Celgene, which is about a 54% premium to Celgene’s closing price Wednesday. Earlier in the day, Thursday Celgene’s shares jumped 31% following news of the merger.

Serial entrepreneur Soon-Shiong acquired a stake in Celgene in 2010 after he sold the pharmaceuticals company he founded, Abraxis, to the biotech for $4.5 billion, and he became the largest individual shareholder in the stock. Soon-Shiong had invented cancer drug, Abraxane, which later became one of Celgene’s blockbuster hits after it was shown in a study to extend the lives of patients with pancreatic cancer.

Still despite the Celgene bump, Soon-Shiong’s net worth is down some $900 million from when he appeared on the Forbes 400 in October 2018 at no. 198; his rank is now no. 203. Soon-Shiong’s stakes in the two publicly-traded businesses he’s founded—NantHealth and NantKwest—are down more than 85% and 50%, respectively, in the last six months.

https://www.forbes.com/sites/michelatindera/2019/01/03/bristol-myers-squibb-and-celgenes-big-winner-los-angeles-billionaire-patrick-soon-shiong/#4ea5f23b423c

Aslan Pharmaceuticals announces IND submission for ASLAN003 to FDA

Aslan Pharmaceuticals announced that the FDA has concluded its 30-day review of the Investigational New Drug, or IND, application for ASLAN003. The company plans to evaluate ASLAN003 in the United States as part of an ongoing Phase 2 clinical trial. ASLAN003 is a potential treatment for acute myeloid leukaemia, or AML, for which the FDA has previously granted Orphan Drug Designation. ASLAN plans to enrol patients in the United States as part of a 20-patient expansion cohort for its ongoing trial, to be conducted once an optimum dose of ASLAN003 in AML has been established. In the United States, clinical sites have been selected and we expect the clinical trial to begin in the first half of 2019. Patients will also be enrolled in the expansion cohort in Singapore and Australia, where the Phase 2a clinical trial is ongoing.

https://thefly.com/landingPageNews.php?id=2843570

Avanos downgraded to Underweight from Equal Weight at Barclays

Barclays analyst Kristen Stewart downgraded Avanos Medical (AVNS) to Underweight and lowered her price target for the shares to $36 from $59. Following a review of the pain medicine landscape the analyst has increased concerns regarding the outlook for the company’s ON-Q Pump. Drug shortages are likely to persist into mid-year, Stewart tells investors in a research note. Further, she has longer-term concerns around the potential FDA approval and launch of Heron Therapeutics’ (HRTX) HTX-011.

https://thefly.com/landingPageNews.php?id=2843572

Varian Medical upgraded to Buy from Neutral at Goldman Sachs

Goldman Sachs analyst Isaac Ro upgraded Varian Medical Systems to Buy and raised his price target for the shares to $129 from $107. The company’s guidance looks conservative given the new China quota, Ro tells investors in a research note. The new, larger quota in China has the ability to grant approximately 1,400 licenses by 2020, about a 50% increase on a per annum basis from the prior quota, says the analyst. He calls Varian an “out of consensus Buy idea” with China driving upside over the next two years.

https://thefly.com/landingPageNews.php?id=2843586

Aerie: ‘Positive’ results from Phase 2 study of netarsudil ophthalmic solution

Aerie Pharmaceuticals announced the topline results of its pilot Phase 2 study of netarsudil ophthalmic solution in a Japanese-American population. The study was designed in accordance with the requirements of Japan’s PMDA to support the potential regulatory submission of netarsudil ophthalmic solution in Japan. Netarsudil ophthalmic solution 0.02% is known by the name Rhopressa in the United States, where it is currently marketed. This pilot study was initially designed as a larger Phase 2 trial to be conducted in the United States, enrolling Japanese subjects and Japanese-American subjects that are within second generation. Due to scarcity of qualified subjects in the United States, the enrollment of this study was limited to approximately 40 subjects across three study arms. The primary objectives of the study were to evaluate (1) the ocular hypotensive activity of two different dose concentrations of netarsudil ophthalmic solution (0.02% and 0.04%) relative to placebo over a 28-day period, for a total of three arms all dosed in the evening, and (2) the ocular and systemic safety of netarsudil ophthalmic solution relative to placebo over that period. The ranges of unmedicated baseline IOP at 8am in the study were greater than or equal to 15 mmHg to less than 35 mmHg for subjects with open-angle glaucoma, and greater than or equal to 22 mmHg to less than 35 mmHg for subjects with ocular hypertension. The results, which are outlined in the supporting slide presentation to this press release, demonstrated that netarsudil ophthalmic solution 0.02% lowered IOP in mean diurnal IOP by a range of 5.0 to 5.3 mmHg for subjects with an average baseline IOP of 18.3 mmHg. The netarsudil ophthalmic solution 0.04% arm lowered IOP in mean diurnal IOP by a range of 5.2 mmHg to 6.6 mmHg for subjects with average baseline IOP of 20.2 mmHg. The placebo arm lowered IOP in mean diurnal IOP by a range of 2.0 to 2.5 mmHg for subjects with an average baseline pressure of 19.6 mmHg. Both netarsudil arms showed higher levels of IOP reduction as compared to placebo to a statistically significant degree at Day 28. The safety findings were consistent with previous netarsudil trials. Aerie expects to initiate a Phase 2 clinical trial in Japan in the first quarter of 2019 structured, as agreed with the PMDA, consistently with this pilot study with the addition of a 0.01% concentration of netarsudil.

https://thefly.com/landingPageNews.php?id=2843638

OraSure to acquire CoreBiome, Novosanis

OraSure announced that it has entered into definitive agreements to acquire two companies. CoreBiome is a privately-held, early-stage microbiome services provider that accelerates discovery for customers in the pharmaceutical, agricultural and research communities. CoreBiome’s proprietary genomics pipeline and algorithms deliver speed and scalability in the lab as well as precise analytics. Novosanis is a privately-held, Belgian company founded as a spinoff company from the University of Antwerp, Belgium, in 2013. Novosanis is an early commercial-stage producer and distributor of urine sample collection devices targeted primarily at the liquid biopsy, sexually transmitted infection screening and urological cancer markets. Novosanis’ primary product technology is Colli-Pee, a device designed for the standardized collection of first-void urine in the privacy of the user’s home or at a clinic. The transactions are structured with an upfront payment and potential additional payments based on future performance. The company expects that the acquisitions will together contribute from $4M-$7M in net revenues in 2019, with 3c-5c per share of dilution to non-GAAP earnings excluding transaction costs and required acquisition accounting adjustments.

https://thefly.com/landingPageNews.php?id=2843688

Boehringer Ingelheim exercises option in research collaboration with Dicerna

Boehringer Ingelheim and Dicerna Pharmaceuticals announced that Boehringer Ingelheim has exercised an option to receive exclusive rights to a second hepatic disease target emerging from its research collaboration and license agreement with Dicerna. The collaboration, established in October 2017, aims to discover and develop novel GalXC RNAi therapeutics for the treatment of chronic liver diseases, with an initial focus on nonalcoholic steatohepatitis, a devastating disease for which there is no approved treatment. The option is the second target under the two companies’ research collaboration and license agreement. Under the terms of the agreement, Boehringer Ingelheim will be responsible for future clinical development and commercialization of the therapeutic target. Dicerna is eligible to receive development and commercial milestone payments, and royalties on worldwide net sales. Dicerna and Boehringer Ingelheim selected the target based on its ability to be drugged using Dicerna’s proprietary GalXC technology platform. The GalXC platform uses RNAi to inhibit the expression of disease-causing genes by destroying the messenger RNAs of those genes. The approach has the potential to treat diseases by silencing previously inaccessible drug targets.

https://thefly.com/landingPageNews.php?id=2843690