BUSINESS INSIGHTS, PHARMA TECH
Indivior | March 06, 2023
Indivior PLC, a global pharmaceutical company, recently announced its successful acquisition of Opiant Pharmaceuticals, Inc. The acquisition strengthens Indivior's addiction treatment and science portfolio by adding Opiant's late-stage assets. In particular, OPNT003, an investigational opioid overdose treatment, aims to provide an effective treatment option to address the current wave of opioid overdose caused by powerful synthetic opioids such as fentanyl.
Indivior acquired Opiant for an upfront consideration of $20.00 per share in cash, summing to approximately $145 million and up to $8.00 per share in contingent value rights (CVRs). The CVRs will become payable if OPNT003 meets certain net revenue milestones within seven years after approval and launch. The acquisition was completed after meeting customary conditions, and Indivior funded the upfront consideration with its existing cash. It expects OPNT003 to generate net revenue of 150 million to 250 million dollars and the acquisition to be earnings accretive after the second year of launch. The company plans to provide updated guidance for FY 2023 with its Q1 results announcement on April 27, 2023.
OPNT003 is a patent-protected intranasal formulation of nalmefene. It employs an absorption-enhancing technology to improve its pharmacokinetic and pharmacodynamic profile, resulting in a fast-acting and long-lasting duration of action that helps OPNT003 as a possible new treatment option for opioid overdose. On December 22, 2022, Opiant completed its rolling NDA for OPNT003. OPNT003's FDA PDUFA date is May 22, 2023. One formulation patent (expiry 2038) and five other patent applications cover various aspects of OPNT003, including treatment methods. National Institutes of Health, National Institute on Drug Abuse (NIDA) is funding the development of the program, as well as an agreement from Biological Advanced Research and Development Authority (BARDA).
About Indivior
A global pharmaceutical company, Indivior, is working to support patients in changing their lives by developing medicines that help in coming out of addiction and severe mental illnesses. The company aims to provide access to evidence-based treatment to all patients globally for chronic conditions and co-occurring disorders of substance use disorder (SUD). It is committed to transforming substance use disorder from a worldwide human crisis to a recognized and treated chronic illness. In addition, it has a pipeline of product candidates designed to build on its global portfolio of OUD treatments and potentially address other chronic conditions and co-occurring disorders of SUD, such as alcohol use disorder and cannabis use disorder.
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BUSINESS INSIGHTS, PHARMA TECH
ClinChoice | March 03, 2023
ClinChoice, a leading global clinical CRO, recently announced that it has acquired CROMSOURCE S.r.l., an ISO-certified full-service contract research organization. CROMSOURCE has its corporate headquarters in Verona, Italy, its US headquarters in Cary, NC, and subsidiaries in the US and seven countries throughout eastern and western Europe.
With a proven track record of providing excellent clinical research and staffing services to multinational pharmaceutical, biotechnology, and medical device clients, CROMSOURCE's acquisition will strengthen ClinChoice's global network and further enhance its full-service capabilities.
ClinChoice is known for its commitment to providing high-quality services and timely delivery, resulting in the successful completion of clinical trials and functions, including regulatory, biometrics, safety, medical, and clinical operations across various sectors such as drug, medical devices, vaccines, cosmetics, and consumer health using both project-based and FSP models.
The company offers services covering the development lifecycle for biotechnology, pharmaceutical, consumer products and medical device companies worldwide. With a broad clientele ranging from the largest multinationals to startup and emerging companies, ClinChoice has completed over 1,500 clinical studies in various therapeutic areas such as CNS, oncology, ophthalmology, rare disease, respiratory and metabolic.
CROMSOURCE's acquisition was advised by Fairmount Partners, while Crosstree Capital represented ClinChoice.
About ClinChoice
ClinChoice is a leading global clinical CRO that provides comprehensive services to biotechnology, pharmaceutical, medical device, and consumer products clients worldwide. With a successful 25-year track record, it is considered the standard for excellence in clinical operations, biostatistics, data management, CDISC, statistical programming, regulatory affairs, medical affairs, and pharmacovigilance. The company has established major delivery centers in Europe, the US, Canada, China, India, Japan, and the Philippines, employing over 3,000 people worldwide. ClinChoice has a strong and talented team and is expanding its clinical operations in seven countries across North America, Asia, and Europe.
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BUSINESS INSIGHTS, PHARMACY MARKET
Harrow | February 16, 2023
On February 15, 2023, Harrow, a renowned pharmaceutical firm specializing in eyecare in the United States, announced the launch of its next-generation, patent-pending compounded Atropine formulations. These formulations are now accessible through ImprimisRx, a mail-order pharmacy subsidiary wholly owned by Harrow.
The following are the key features of ImprimisRx's next-generation Atropine formulations
Thoroughly validated analytical tests are conducted to ensure potency, consistency, and stability.
The formulations are free of preservatives and boric acid.
They possess a physiologic pH of 5.5.
They can be stored at room temperature for up to 180 days.
Eyecare professionals can purchase these compounded Atropine formulations for as less as $39 per 5mL bottle through various channels, such as online via atropine.com or by contacting ImprimisRx Customer Service at 615-437-4690 via call or text.
Compounded formulations are recommended for patients with clinical requirements that are not met by FDA-approved medications. It is essential to note that compounded medications are not reviewed by FDA for their safety and effectiveness. ImprimisRx does not manufacture copies of products that are already available in the market.
Harrow's Chairman and Chief Executive Officer, Mark L. Baum, commented, "Our mission has always been to help our eyecare professionals address their patients' unmet needs and to make ophthalmic medications both accessible and affordable. The availability of these innovative compounded atropine formulations is in keeping with our mission. We believe ophthalmologists, optometrists, and the millions of Americans who may benefit from topical atropine therapy, will appreciate the tremendous value these patent-pending formulations offer."
(Source – Business Wire)
About Harrow
Founded in 2012, Harrow is a leading ophthalmic pharmaceutical firm in the United States focused on discovering, developing, and introducing accessible, innovative, and affordable prescription therapies. It holds commercial rights for ten FDA-approved eyecare pharmaceutical products. In addition, the company also operates ImprimisRx, a leading U.S. compounding business that specializes in ophthalmic medications and is licensed to ship prescription drugs in all 50 states. The success of its efforts is reflected in its remarkable financial performance, with a 72% compound annual growth rate achieved during our first eight years in operation. This phenomenal growth rate has established Harrow as one of the fastest-growing ophthalmic pharmaceutical companies in the United States.
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