Prosecutors strike yet another pharma kickback settlement, this time with Almirall

fiercepharma | May 30, 2019

One by one, drugmakers have been handing over millions of dollars to the U.S. government to settle kickback allegations. And Almirall is the latest.The Spain-based drugmaker agreed to pay $3.5 million to the Department of Justice (DOJ) and $3.1 million to the California Department of Insurance to wrap up claims that it paid doctors to prescribe more of its skin drugs. Based on allegations outlined in a whistleblower lawsuit, the government said that Almirall's Aqua Pharmaceuticals business wined, dined, entertained and gave gifts to dermatologists to boost scripts. Almirall bought Aqua in 2013, and the alleged kickbacks extended from 2012 to 2017, the DOJ said.  The company also used speaking events, advisory boards and more to influence prescribing habits, the feds alleged, focusing on three meds Monodox, Cordran and Acticlate Almirall’s wrap-ups are the latest in a string of pharma kickbacks settlements, many of them related to charity contributions. The Justice Department has said certain donations actually served as kickbacks designed to boost sales. At least 10 drugmakers have settled those claims with the DOJ: Astellas, Amgen, Actelion, Aegerion, Jazz, Alexion, Lundbeck, Pfizer, Novartis and United Therapeutics.

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Expenditures in pharmaceutical R&D are higher than ever, and attrition rates have reached 80-90%. The few compounds that make it to market have to carry the cost of the inefficient development process, but hope lies in improving the data that flows into lead discovery and optimization.


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BUSINESS INSIGHTS

Akorn Announces FDA-approved Generic Cetrorelix Acetate for Injection 0.25 mg

Akorn Pharmaceuticals | August 17, 2022

Akorn Operating Company LLC, a specialty pharmaceutical company, announces that it received FDA approval for a generic version of Cetrorelix Acetate for Injection, 0.25 mg. This is the first approved AP-Rated bioequivalent version of Merck Serono's Cetrotide®.1 "We are pleased to announce the first approved AP-rated generic option for women receiving fertility treatments. As an increasing number of infants are being conceived via the use of ART, Akorn is excited to be able to offer a competitively priced option to support women who undergo this series of treatments. This is a welcome addition to our portfolio of more than 200 specialty and injectable generics." Akorn President and CEO Douglas Boothe Assisted Reproductive Technology (ART) is defined as fertility treatments where eggs or embryos are handled for the purpose of establishing a pregnancy. 2 The FDA granted Akorn a Competitive Generic Therapy (CGT) designation for Cetrorelix, a designation intended to incentivize effective development, efficient review, and timely market entry of drugs for which there is inadequate generic competition. As the first approved applicant with the CGT designation, Akorn's Cetrorelix is eligible for 180 days of CGT market exclusivity, which will begin to run from the commercial launch of Cetrorelix. According to IQVIA, U.S. sales of Cetrorelix through June of 2022 were approximately $63 million with full year U.S. sales projection of approximately $127 million. About Cetrorelix Acetate for Injection 0.25 mg Cetrorelix is used to prevent premature ovulation during controlled ovarian stimulation. Cetrorelix blocks the effects of a natural hormone, called gonadotropin‐releasing hormone (GnRH). GnRH controls the secretion of another hormone, called luteinizing hormone (LH), which induces ovulation during the menstrual cycle. During hormone treatment for ovarian stimulation, premature ovulation may lead to eggs that are not suitable for fertilization. Cetrorelix Acetate for Injection blocks such undesirable premature ovulation. About Akorn Akorn Operating Company LLC, develops, manufactures and markets specialty pharmaceuticals. Since 1971, as an industry leader in generic products in alternate dosage forms such as ophthalmics, injectables, oral liquids, otics, topicals, inhalants and nasal sprays, we focus each day on our mission to improve lives, through the quality, availability and affordability of our products.

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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.

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PHARMA TECH

Babson Diagnostics and Pharmacy Podcast Network Announce Partnership That Will Take Listeners Inside Largest Retail Pharmacy Trade Show

Babson Diagnostics | July 27, 2022

Babson Diagnostics, a science-first, health care technology company, announced a media partnership with the Pharmacy Podcast Network in connection with the 2022 National Association of Chain Drug Stores’ Total Store Expo, the largest gathering of retailers and suppliers in the health and wellness industry. As part of the partnership, the Pharmacy Podcast Network, the most popular and downloaded podcast about the pharmacy industry, will be integrated into Babson Diagnostics’ booth at the Total Store Expo. Todd Eury, founder and chief executive officer of the media company, will host podcasts from the booth featuring industry leaders attending the trade show. In addition, Babson will sponsor two podcasts that will be broadcast prior to the expo, which takes place Aug. 27 through Aug. 29 in Boston. The first of those shows, “Diagnostic Testing in Community Pharmacies,” went live today. “Babson is excited to be collaborating with one of the leading media outlets aimed at community pharmacists, who are the face of neighborhood healthcare. Babson is working with pharmacies to offer medically accurate blood testing that is easier, more convenient and less invasive than traditional methods.” David Stein, CEO of Babson Diagnostics Launched in 2009, the Pharmacy Podcast Network reaches more than 80,000 listeners per month with audio content focused on the critical role pharmacists play in the healthcare industry. “I look forward to bringing exciting new content to my audience through this partnership with Babson Diagnostics,” Eury said. “The Total Store Expo is a one-of-a-kind opportunity to bring insights to pharmacists about new and innovative products and services in health and wellness, such as Babson’s blood-testing ecosystem.” About Babson Diagnostics Babson Diagnostics is a science-first healthcare technology company bringing convenient, medically accurate diagnostic blood testing to the local pharmacy. We are the first and only company to do broad blood panels from a capillary microsample, collected from a finger, at a retail setting. Our core technology was incubated at Siemens Healthineers ​in 2015, and we became Babson Diagnostics in 2017. We have exclusive partnerships with Siemens Healthineers and BD (Becton, Dickinson and Company), two global leaders in healthcare innovation and medical technology. Together we are reimagining the entire blood testing process, helping people get the care they need, when they need it. Babson, based in Austin, Texas, is named in honor of Art Babson, whose legacy of scientific innovation and excellence is the foundation on which the company is built. About Pharmacy Podcast Network Pharmacy Podcast Nation is the flagship show hosting all of the Pharmacy Podcast Network 1400+ episodes. With more than 30 different podcast programs and some 40 different co-hosts helping to develop audio content about the pharmacy sector, its reach includes communities, hospitals, senior-care residences, military and public health settings that meet the information needs of 300,000 pharmacists with more than 100,000 monthly listeners. PPN also delivers a unique publication called Rx Influencer to all healthcare professionals with a specific focus on pharmacy.

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BUSINESS INSIGHTS

Element Materials Technology Announces Completion of its Acquisition by Temasek

Element and Temasek | July 08, 2022

Element Materials Technology a global leader in testing, inspection, and certification services, has completed its acquisition by Temasek, a global investor headquartered in Singapore. Temasek has been a minority shareholder in Element since 2019. Temasek has acquired Element from Bridgepoint, whose successful ownership has been an important part of a more than ten-fold increase in Element’s turnover over the past decade. The acquisition, which was subject to regulatory approvals, was previously announced on 25th January 2022. As a highly differentiated TIC leader with a track record of technical expertise, Element is a trusted partner to customers, supporting them from early R&D, through complex government approvals, and into production, with a focus on laboratory-based testing. Its 7,000+ scientists, engineers, and technologists, based across a global network of more than 200 laboratories in 30 countries, serve technically demanding and highly regulated sectors, ensuring products are safe and sustainable. Element works with customers across a wide spectrum, from developing the next generation of aircraft, spacecraft, and autonomous vehicles, to vaccine component testing in its US pharmaceutical laboratories; and from the certification of smartphones and wearable technologies, to providing 5G carrier approvals and developing connected robots. The Group generates annual revenues of more than $1 billion and has grown at over 20% a year over the last ten years. It is well-positioned to accelerate this growth as it builds deeper leadership positions in critical end-markets including life sciences and connected technologies. Element also benefits from strong global ESG tailwinds - with over 60% of its work directly supporting customers on their sustainability journeys, it will continue to play a critical role in the decarbonization of the global economy. “We are delighted to complete this landmark transaction with Temasek, and to begin work on the next chapter of Element’s story. Their partnership over the last three years has been hugely beneficial to our growth. Today, Element is the partner of choice to companies at the forefront of innovation, from advanced medical science to autonomous cars, and has one of the most talented and highly qualified teams in the TIC space. Jo Wetz, CEO of Element We are excited to build upon that legacy of success and drive Element forward by scaling our business further through strategic investments and acquisitions, with a focus on high growth end-markets such as life sciences and connected technologies. Element will continue to play a crucial role in supporting our customers on their sustainability journeys, and in making tomorrow safer than today.” Allan Leighton, Non-Executive Chairman of Element, said: “Element is a true success story – a talented management team leading an exceptional group of experts across offices and laboratories in more than 30 countries around the world. We’re now entering another exciting chapter of purpose-driven growth, together with our customers and our new owners”. Chris Busby, partner at Bridgepoint, said: “Element has been bold in its ambition, delivered impressive organic growth, and implemented a targeted acquisition strategy. As a result, it has significantly expanded its expertise for over 50,000 customers worldwide and become an undisputed heavyweight in TIC. We are proud of what Element has achieved and wish them continued success in the future.” Element was advised by Bank of America Securities, Goldman Sachs and Rothschild & Co A&O EY BCG DLA, Jamieson and PwC. About Element The Element Materials Technology Group is one of the world’s leading global providers of testing, inspection, and certification services for a diverse range of products, materials, and technologies in advanced industrial supply chains where failure in use is not an option. Headquartered in London, UK, Element’s c.7,000 scientists, engineers, and technologists, working in our global network of over 200+ laboratories, support customers from early R&D, through complex regulatory approvals, and into production ensuring their products are safe and sustainable, and achieve market access. In 2021, Element set out its new, industry leading environmental commitments, adopting science-based targets and committing to net zero emissions across its entire global business by 2035. These environmental commitments follow Element’s achievement of the highest ESG ranking in the testing, inspection and certification industry from Sustainalytics, a global leader in ESG research and data. About Temasek Temasek is a global investment company with a net portfolio value of S$381 billion as at 31 March 2021. Headquartered in Singapore, it has 13 offices in nine countries around the world. The Temasek Charter defines Temasek’s three roles as an Investor, Institution, and Steward, which shape its ethos to do well, do right, and do good. As a provider of catalytic capital, it seeks to enable solutions to key global challenges. With sustainability at the core of all Temasek does, it actively seeks sustainable solutions to address present and future challenges, as it captures investible opportunities to bring about a sustainable future for all.

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Spotlight

Expenditures in pharmaceutical R&D are higher than ever, and attrition rates have reached 80-90%. The few compounds that make it to market have to carry the cost of the inefficient development process, but hope lies in improving the data that flows into lead discovery and optimization.

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