Celgene, say goodbye to Otezla: BMS agrees to sell psoriasis drug to clear $74B merger

fiercepharma | June 24, 2019

With the Federal Trade Commission (FTC) sweating the details of Bristol-Myers Squibb and Celgene’s proposed $74 billion merger, all eyes were on the companies’ combined psoriasis portfolio, which regulators feared would corner the market. The feds found a solution: You can have your merger, but you don’t get to keep Celgene's blockbuster Otezla. Bristol-Myers will sell the psoriasis pill as part of a consent decree with the FTC intended to speed up its Celgene merger, the company said. Otezla, which cleared more than $1.6 billion in global sales in 2018, was not considered one of the core assets in the merger, according to Credit Suisse analyst Vamil Divan. The divesture will likely delay the merger's approval until late 2019 or early 2020, overshooting plans for a Q3 approval this year, Bristol-Myers said. "Bristol-Myers Squibb is committed to working with regulatory authorities around the world on the proposed combination with Celgene,” Bristol-Myers said in a statement. “The company is focused on realizing the promise of the transaction, and is continuing to work to complete the transaction on a timely basis.” In snap reactions to the news Monday, analysts expressed a common thought: surprise. Jefferies analysts said targeting Otezla, which competes with five to seven major competitors in psoriasis and isn’t considered a “dominant power,” revealed the FTC’s tight strategy on pharma M&A. “We believe this is a (potential) read-through that the FTC is being tougher on regulating competition,” the analysts said. Divan said there could be multiple buyers for Otezla, but Bristol-Myers’ leverage in a potential sale would be limited with the mandatory nature of the castoff.

Spotlight

Animal toxins present a major threat to human health worldwide, predominantly through snakebite envenomings, which are responsible for over 100,000 deaths each year. To date, the only available treatment against snakebite envenoming is plasma-derived antivenom. However, despite being key to limiting morbidity and mortality among snakebite victims, current antivenoms suffer from several drawbacks, such as immunogenicity and the high cost of production. Consequently, avenues for improving envenoming therapy, such as the discovery of toxin-sequestering monoclonal antibodies against medically important target toxins through phage display selection, are being explored.


Other News
PHARMA TECH

AeroRx Partners with HCmed to Develop a Nebulized LABA/LAMA Combination Solution for the Treatment of Chronic Obstructive Pulmonary Disease

AeroRx Partners | October 03, 2022

AeroRx Therapeutics, LLC. and HCmed Innovations Co., Ltd. have initiated a collaboration, introducing a LABA/LAMA combination solution for delivery with a breath-actuated nebulizer. This collaboration sets forth the framework by which both companies will work together to develop a new nebulized combination formulation for the treatment of chronic obstructive pulmonary disease. According to market reports, it is estimated that there would be close to 34.5 million COPD patients worldwide by 2028, accounting for treatment global sales that could reach up to 19.3 billion USD. AeroRx is currently developing the first nebulized LABA/LAMA combination solution, which could benefit 7-19% of the COPD population. This population group is characterized for suffering from moderate to severe airflow obstruction, which creates difficulties to achieve the inspiratory flow rate required to use most dry powder inhalers optimally. Under this partnership, AeroRx will be responsible for the formulation development, clinical trials, and commercialization of the drug product, while HCmed will be responsible for the customization of the AdheResp breath-actuated nebulizer platform, analyzing and optimizing the formulation's aerosol characterization performance to accommodate the various stages of drug development process and the final combination product. The project will follow a 505(b)2 regulatory pathway, and the corresponding PK/PD study is expected to be conducted with HCmed's nebulizer in 2023. "We are excited to announce our partnership with AeroRx. The AeroRx team has extensive experience in the development of respiratory drugs, while at HCmed we can support our partners to develop drug-nebulizer combination products with our proprietary breath-actuated mesh nebulizer platform. The product of our collaboration will provide COPD patients with an effective inhaled LABA/LAMA combination drug, which will reinforce patients' treatment adherence and improve their quality of life." Jason Cheng, CEO and founder of HCmed Keith Ung, President and co-founder of AeroRx also commented, "We too are enthusiastic about this partnership. Breath-actuated vibrating mesh delivery of inhaled therapeutics is the wave of the future for many therapeutics and HCmed has become one of the leaders in this elegant inhaler device technology." About HCmed Founded in 2014, HCmed Innovations Co., Ltd. is a contract development and manufacturing organization that provides high-quality and cost-effective vibrating mesh nebulizer technology and services to support global pharmaceutical partners in the development of drug-nebulizer combination products for inhalation therapy. HCmed offers a mature customizable mesh nebulizer platform to enhance drug delivery. This technology enables efficient and reliable nebulization of different types of medication, ranging from small molecule synthetics to large molecule biologics, as either solutions, suspensions, or even difficult-to-deliver high viscosity drugs. About AeroRx Founded in 2022, AeroRx Therapeutics, LLC. is a spin-off of iPharma Lab's inhalation CDRO business which was recently acquired by Kindeva Drug Delivery. AeroRx is developing proprietary inhaled products for the treatment of COPD and asthma. The company is led by industry veterans with extensive expertise in inhaled drug delivery and development as well as a track record in building new pharmaceuticals organizations from the ground up.

Read More

BUSINESS INSIGHTS

Ligand Pharmaceuticals Announces Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

Ligand Pharmaceuticals | August 02, 2022

Ligand Pharmaceuticals Incorporated announced that effective August 1, 2022, Ligand’s Board of Directors approved the grant of non-qualified stock option awards to purchase an aggregate of 90,073 shares of its common stock, 5,000 restricted stock units and 4,000 performance stock units the target level to six non-executive employees. The options were granted on August 1, 2022, and the grant date for the RSUs and the PSUs will be the date on which Ligand files a Form S-8 Registration Statement to register the shares pursuant to Ligand’s 2022 Employment Inducement Plan. The awards were granted under the Inducement Plan as employment inducement awards pursuant to NASDAQ Listing Rule 5635(c)(4). The Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of Ligand, or following a bona fide period of non-employment, as an inducement material to such individuals’ entering into employment with Ligand, pursuant to Nasdaq Listing Rule 5635(c)(4). The options have an exercise price of $89.70 per share, which is the closing price of Ligand’s common stock on The Nasdaq Global Select Market on August 1, 2022. The stock options have a term of ten years and will vest over four years, with 12.5% of the shares vesting six months after the employee’s commencement of employment and the balance of the shares vesting in 42 equal monthly installments thereafter, subject to the grantee’s continued service on such vesting dates. The RSUs will vest over three years on the first three anniversaries of the grantee’s commencement of employment, subject to continued service through each applicable vesting date. The PSUs will vest based on the achievement of certain total shareholder return objectives and the completion of the contemplated spin-off of OmniAb, Inc. from Ligand. The number of shares earned under the PSUs may be up to 6,500 in the aggregate if maximum performance levels are achieved. About Ligand Pharmaceuticals Ligand is a revenue-generating biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. Our business model creates value for stockholders by providing a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Our goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable, diversified and lower-risk business than a typical biotech company. Our business model is based on doing what we do best: drug discovery, early-stage drug development, product reformulation and partnering. We partner with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) ultimately to generate our revenue. Ligand’s OmniAb® technology platform is a patent-protected transgenic animal platform used in the discovery of fully human monoclonal and bispecific therapeutic antibodies. The Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand’s Pelican Expression Technology® is a robust, validated, cost-effective and scalable platform for recombinant protein production that is especially well-suited for complex, large-scale protein production where traditional systems are not. Ligand has established multiple alliances, licenses and other business relationships with the world’s leading pharmaceutical companies including Amgen, Merck, Pfizer, Sanofi, Janssen, Takeda, Gilead Sciences and Baxter International.

Read More

BUSINESS INSIGHTS

Model N and Pfizer Innovate Drug Price Transparency Reporting

Model N, Inc. | August 04, 2022

Model N, Inc. the leader in revenue optimization and compliance, announced the launch of Transparency Talks, a new, three-part education series for pharmaceutical companies that tackles the topic of price transparency regulations for prescription drugs. Transparency Talks will bring together leaders from Model N, Pfizer and Global Pricing Innovations (GPI) to explore state drug pricing laws and regulations, as well as facilitate a discussion on trends, best practices and innovative approaches that help pharmaceutical companies meet regulatory compliance goals. First-Ever SaaS Solution for State Price Transparency Mandates Model N has pioneered a technology-driven approach to state price transparency regulations. Its new State Price Transparency Management (SPTM) solution for the Model N Revenue Cloud is the first-ever SaaS solution built specifically to assist pharmaceutical and biotech companies in operationalizing the complete, end-to-end process for meeting State Price Transparency mandates. “Life sciences companies must find an effective way to prepare and respond to fast-moving changes in state price transparency regulations, and we are excited to deliver innovative solutions to help them avoid costly mistakes. t’s been an honor to partner with Pfizer on State Price Transparency Management, creating an innovative solution that helps navigate the fluid state drug price reporting landscape.” Kyle Forcier, Senior Director of Life Sciences Product Marketing at Model N Pfizer and GPI on SPTM The SPTM solution was developed with the collaboration of Pfizer, the world’s largest pharmaceutical company. “Our collaboration with Model N has delivered a tool that helps us better manage complex state reporting requirements,” said Laura Topal, Senior Director, Strategic Pricing, Pfizer. “We’re proud of what we have achieved together, and we’re excited about sharing our learnings with the larger pharma community.” Rachel Jao, Head of Commercial Strategy from GPI, a market leader in innovative solutions for biopharma and market access, will also join Transparency Talks to share the latest in industry best practices. “More than 20 states have drug pricing transparency laws on the books today, and there can be severe financial consequences for non-compliance,” Jao said. “Transparency Talks from Model N is a valuable way for pharma business leaders to learn more about the current regulatory environment and to explore solutions that will help them address this significant challenge.” About Model N Model N is the leader in revenue optimization and compliance for pharmaceutical, medtech and high-tech innovators. Our intelligent platform powers your digital transformation with integrated technology, data, analytics, and expert services that deliver deep insight and control. Our integrated cloud solution is proven to automate pricing, incentive and contract decisions to scale business profitably and grow revenue. Model N is trusted across more than 120 countries by the world’s leading pharmaceutical, medical technology, semiconductor, and high-tech companies, including Johnson & Johnson, AstraZeneca, Stryker, Seagate Technology, Broadcom, and Microchip Technology.

Read More

BUSINESS INSIGHTS

SCA Pharma Names Louis Pace as Chief Financial Officer and Chief Information Officer

SCA Pharma | July 15, 2022

SCA Pharma, a nationally recognized leader in the 503B compounding pharmaceuticals outsourcing industry providing quality, service, and value to hospitals nationwide, has announced today the addition of Louis Pace as Chief Financial Officer and Chief Information Officer. Pace brings over 30 years of experience serving several successful private equity backed businesses in functional and P&L leadership roles. Most recently, Mr. Pace served as Chief Financial Officer at Orchid Orthopedic Solutions where he successfully led strategy deployment efforts that focused on growth and profitability improvement. "I am extremely excited to welcome Louis to the team and to partner with him as we continue to accelerate growth at SCA Pharma. SCA Pharma is committed to providing innovative solutions for our 503B customers that help health systems manage their drug supply chain and pharmacy operations more efficiently. That evolution requires a more strategic and diversified approach, which suits Louis' background. Louis will manage our finance and accounting teams as well as our information technology strategy. He will concentrate on prioritizing internal and external business opportunities." Scott Luce, CEO of SCA Pharma "I am looking forward to working with the exceptional team at SCA Pharma. I am excited to build on SCA Pharma's current success and be a part of the company's future growth," said Louis Pace. Mr. Pace holds an AB in Economics from Harvard University and an MBA from Northwestern Kellogg Graduate School of Management. About SCA Pharma SCA Pharma is a nationally recognized leader in the FDA 503B outsourcing industry, specializing in providing the highest quality sterile admixture services and pre-filled syringes to hospital and health-care facility pharmacies. The company serves all therapeutic areas of pharmacy — including critical care, labor and delivery, anesthesia, and pain management — and maintains a wide portfolio of products, including ready-to-use and drug-shortage medications.

Read More

Spotlight

Animal toxins present a major threat to human health worldwide, predominantly through snakebite envenomings, which are responsible for over 100,000 deaths each year. To date, the only available treatment against snakebite envenoming is plasma-derived antivenom. However, despite being key to limiting morbidity and mortality among snakebite victims, current antivenoms suffer from several drawbacks, such as immunogenicity and the high cost of production. Consequently, avenues for improving envenoming therapy, such as the discovery of toxin-sequestering monoclonal antibodies against medically important target toxins through phage display selection, are being explored.

Resources