Baxter Gets FDA OK on Bioactive Bone Graft in Posterolateral Spine Surgery

 Baxter International, Inc. (NYSE:BAX), a global leader in advancing surgical innovation, today announced U.S. Food and Drug Administration (FDA) clearance of ALTAPORE Bioactive Bone Graft, a next-generation bioactive and osteoconductive bone graft substitute, for use as an autograft extender in posterolateral spinal fusion. ALTAPORE had previously been cleared for use in orthopedic surgical procedures in the extremities and pelvis.

ALTAPORE is designed to enhance bone growth with optimized porosity that promotes earlier vascularization, which plays a central role in the bone formation process by providing oxygen, nutrients, and growth factors critical for bone development. ALTAPORE’s porosity also increases cellular activity by providing more surface area for cells to travel along the surface of the graft, which promotes new bone formation. Additionally, ALTAPORE’s unique chemistry contains 0.8 percent silicon by weight, which was shown to be optimal for bone formation in preclinical studies.

“ALTAPORE utilizes Baxter’s proprietary silicate-substituted technology and has an enhanced porosity that provides for earlier vascularization, increased cellular activity and improved volume of new bone growth. I’ve had a good experience with ACTIFUSE bone graft substitute, and am looking forward to taking advantage of the novel characteristics of ALTAPORE for my patients,” said Roger Härtl, M.D., professor of Neurological Surgery, director of Spinal Surgery, and director of the Weill Cornell Medicine Center for Comprehensive Spine Care in New York.

ALTAPORE has been formulated to meet surgeons’ needs, as it is easy to store, handle and implant. Its precise handling characteristics allow the putty to be molded into multiple shapes to adapt to various surgical needs. Additionally, in a pre-clinical posterolateral spinal fusion model, ALTAPORE used as an autograft extender exhibited similar fusion rates to iliac crest autograft, which is considered the current standard of care in spine surgical techniques. The iliac crest is an area of the pelvis commonly used for acquiring autogenous bone graft.

“Providing surgeons with versatile tools like ALTAPORE is critical to our commitment to partner with clinicians to advance healing in the operating room,” said Wil Boren, president of Baxter’s Advanced Surgery business. “With this clearance, more surgeons will have access to this innovative bone graft substitute as we look to improve outcomes across our entire portfolio of surgical products.”

ALTAPORE Bioactive Bone Graft is the latest addition to Baxter’s growing osteobiologics portfolio of surgical products, which includes Actifuse Shape, Actifuse MIS, Actifuse ABX and Actifuse Flow. Baxter received 510(k) clearance for the use of ALTAPORE as an autograft extender in posterolateral spine in August 2018. The company has started the process of packaging inventories carrying the new FDA-approved labeling and expects to start selling product in the United States by year-end. Baxter intends to unveil ALTAPORE at the 2018 North American Spine Society annual congress Sept. 26-29 in Los Angeles.

https://www.biospace.com/article/releases/baxter-announces-u-s-fda-clearance-of-altapore-bioactive-bone-graft-in-posterolateral-spine-surgery/

Is NASH Really a $35 Billion Opportunity?

Is NASH Really a $35 Billion Opportunity? And could it be the middle of the pack that wins the prize?

For the last few years, investors have been talking up the huge potential of drugs to treat nonalcoholic steatohepatitis, also known as NASH. An outgrowth of the obesity epidemic in western countries and elsewhere around the globe, NASH is a form of fatty liver disease. It causes scarring and inflammation and is estimated to affect over 16 million people in the U.S. alone.

Meanwhile, nonalcoholic fatty liver disease (NAFLD), a precursor condition marked by high fat content in the liver, may affect some 80 million people in the U.S. Neither NASH nor NAFLD have any current treatment, and can eventually advance to serious fibrosis, and then to full-blown cirrhosis or cancer. In fact, now that the public health impact of hepatitis C has started to recede, NASH is taking over as the leading cause of liver cancer and transplant. It’s the rare case of a disease that is both common and widespread yet has no pharmacologic options. No surprise that a lot of companies are going after it with a vengeance.

This month, Viking Therapeutics just raised its profile in the race, announcing positive phase 2 results for VK2809, a thyroid receptor agonist. Notably, VK2809 isn’t going after NASH but the broader category of NAFLD, and it just showed an impressive ability to lower liver fat content in this population—albeit in a small study. That pits it directly against Madrigal Pharmaceuticals, which is further ahead with its own thyroid receptor agonist for NAFLD, called MGL-3196. Viking’s drug appears superior at first glance, although differences in the clinical trials should limit any firm conclusions. Nonetheless, the company wasted no time raising $176 million in a secondary offering.

Neither Viking or Madrigal are likely to catch up to the leaders in the field, namely Intercept Pharmaceuticals and GENFIT. Both of these companies have drugs in phase 3. Intercept’s drug, Ocaliva (Obeticholic acid) is actually already approved to treat primary biliary cholangitis, and has produced some impressive phase 2 results in NASH—but also has some considerable safety issues. Genfit’s elafibranor, A PPAR agonist, is perhaps more controversial, as it advanced to phase 3 on a subgroup analysis from a failed phase 2 study. Nevertheless, these two companies are viewed as the likely winners of the NASH race.

The Great Middle

But what if it is the middle of the pack that comes out ahead? A number of large pharma companies are also involved in the NASH race. Allergan got in through the $1.7 billion acquisition of Tobira Therapeutics and its drug Cenicriviroc, a dual antagonist of C-C chemokine receptor types 2 and 5. Gilead Sciences got selonsertib, an inhibitor of apoptosis signal-regulating kinase 1, through the $1.2 billion acquisition of Nimbus Therapeutics. Both of these are in phase 3. Novo Nordisk has Semaglutide in phase 2. (Shire Pharmaceuticals had volixibat, but this program was quietly halted earlier this summer.)

These companies could actually turn out to be in the strongest position.

It’s a curious thing that with so many millions of people suffering from unaddressed NASH, getting patients enrolled in clinical trials has been oddly difficult. It has tripped up both Intercept and Genfit.

That’s not because NASH is a fantasy, but because it is widely unrecognized by patients and physicians alike, and because it is hard to diagnose even when it is suspected. As a “silent” killer, it can advance without symptoms for a long time, before finally causing jaundice, fatigue, or weight loss in later stages.

Therefore, even a drug that successfully halts or reverses fibrosis (scarring) and/or resolves NASH (inflammation and some other factors) could have a tough time finding market traction.

Any company hoping to tap the NASH market will be counting on the development of biomarkers and diagnostics, as well as an education campaign—something that could favor the deeper-pocketed pharma companies.

Investment banking firm Cowen has estimated that 30% of patients with the disease are at the F3 (pre-cirrhosis) stage, with another 20% and the less advanced F2 stage. But a study from the New England Journal of Medicine suggests the numbers are smaller—with just 25% of patients at F2 or beyond. Gilead has suggested that there may be around 400,000 patients in the U.S. with diagnosed F3 or F4 NASH—still a very significant market, and one where a well-prepared company could potentially hit the ground running.

That also happens to fit right into the sweet spot for Gilead and what (little) we know about selonsertib. Gilead and Intercept are both expecting phase 3 readouts in the first half of 2019. Even if selonsertib doesn’t look as strong as Ocaliva, Gilead could develop a market while it continues to advance combination products—notably around its own FXR programs, similar to Ocaliva. Intercept may have a winner on its hands, but somebody else may still eat their cake.

https://www.biospace.com/article/is-nash-really-a-35-billion-opportunity-/

Brooks Automation Advances in Life Sciences with $450M Deal for Genewiz

Automation and cryogenics specialist Brooks Automation Inc. will increase its toehold in the life sciences industry with a $450 million all-cash acquisition of New Jersey-based GENEWIZ Group, a genomic services group.

The acquisition of privately-held Genewiz is the largest life sciences move Brooks Automation has made to date, said Steve Schwartz, president and chief executive officer of Brooks Automation. By acquiring Genewiz, Brooks will gain a company that specializes in the important area of gene sequencing and synthesis services. Genewiz has more than 4,000 global customers and has laboratories in multiple parts of the world, including the U.S., China, Japan, Germany and the United Kingdom.

For Brooks, the acquisition of Genewiz comes about a month after the company sold its semiconductor business for $675 million. At the time of that deal, Schwartz said the company planned to use the proceeds to accelerate the growth of its life sciences business, the Boston Business Journal reported. The Journal noted that Brooks largely built its business on the back of the semiconductor side of things, but in 2011 began to move further into the life sciences.

Schwartz said Brooks Automation eyed the Genewiz acquisition as more than just another asset to have in its portfolio. Schwartz said Genewiz will “add a new and innovative platform which we expect to leverage, along with our core capabilities, to add even more value to samples under our care.” Brooks, which is headquartered in Chelmsford, Mass., currently provides its cryogenics expertise to the life science industry. The company’s life sciences offerings include a broad range of products and services for on-site infrastructure for sample management in ‑20°C to -190°C temperatures, as well as comprehensive outsource service solutions across the complete life cycle of biological samples including collection, transportation, processing, storage, protection, retrieval and disposal.

“The Genewiz team has built a strong business, which customers trust to provide industry-leading scientific capabilities and superior service,” Schwartz said in a statement.

Amy Liao, co-founder and CEO of Genewiz, will continue to helm the company after it becomes a Brooks subsidiary.

“We bring 20 years of experience, leading sequencing and synthesis capabilities, deep customer relationships, and more than 1,000 very excited employees into Brooks.  We know that Brooks’ strength in the sample management market will open more doors to customers for our services and we look forward to developing this exciting new chapter of growth together as part of the Brooks team,” Liao said in a statement.

The deal is expected to close by the end of the year barring any unforeseen regulatory issues.

In its announcement, Brooks said it anticipates Genewiz will exceed $140 million in revenue over the next 12 months. That projection corresponds to Brooks’ fiscal year. The company said it anticipates the acquisition will immediately be accretive to non-GAAP earnings.

Shares of Brooks Automation are up slightly in premarket trading to $32.62. The stock fell more than 5 percent on Tuesday to close at $32.14.

https://www.biospace.com/article/brooks-automation-moves-further-into-life-sciences-with-450-million-deal-for-genewiz-group/

Molina Healthcare price target raised to $165 from $134 at Piper Jaffray

Piper Jaffray analyst Sarah James raised her price target for Molina Healthcare to $165 and keeps an Overweight rating on the shares. Puerto Rico finalized the auto assignment process for the $2.2B contract starting November 1, and while Molina is is not confirming the impact, the analyst believes it could be a $150M revenue headwind for the company. Nonetheless, James feels confident in the company’s Q3 results. She believes much of the turnaround success demonstrated in Q2 “will continue to have lasting impacts such as network design and contracting and admin. efficiency.”

https://thefly.com/landingPageNews.php?id=2795569

Alexion to acquire Syntimmune for upfront payment of $400M

Alexion Pharmaceuticals and Syntimmune announced that they have entered into a definitive agreement for Alexion to acquire Syntimmune, a clinical-stage biotechnology company developing antibody therapeutics targeting the neonatal Fc receptor. SYNT001 – a humanized monoclonal antibody that inhibits the interaction of FcRn with Immunoglobulin G and IgG immune complexes – has the potential to improve treatment in a number of rare IgG-mediated diseases. SYNT001 is currently being evaluated in Phase 1b/2a studies in patients with warm autoimmune hemolytic anemia and in patients with pemphigus vulgaris or pemphigus foliaceus and has demonstrated proof of mechanism showing rapid IgG reduction. Under the terms of the agreement, Alexion will acquire Syntimmune for an upfront payment of $400M, with the potential for additional milestone-dependent payments of up to $800M, for a total value of up to $1.2B. Alexion’s acquisition of Syntimmune is subject to the satisfaction of customary closing conditions, including approval from relevant regulatory agencies. Pending these approvals, the transaction is expected to close in the fourth quarter of 2018. Alexion intends to finance the acquisition through cash on hand.

https://thefly.com/landingPageNews.php?id=2795587

Seattle Genetics price target raised to $85 from $77 at JPMorgan

JPMorgan analyst Cory Kasimov raised his price target for Seattle Genetics to $85 saying he’s bullish on the potential success of ECHELON-2, which is expected to readout in Q4. The analyst, however, thinks expectations from investors are “relatively high.” Nevertheless, another successful readout and material line extension for Adcetris could help maintain the stock’s “impressive recent momentum,” Kasimov tells investors in a research note. He keeps an Overweight rating on Seattle Genetics.

https://thefly.com/landingPageNews.php?id=2795595

Merck board rescinds mandatory CEO retirement policy

Merck announced that its Board of Directors has rescinded its policy subjecting the company’s CEO to mandatory retirement at age 65. Merck also announced that its current CEO, Kenneth Frazier, has agreed to remain in his position beyond December 2019, when he turns 65.

https://thefly.com/landingPageNews.php?id=2795601