Cosette Pharmaceuticals, Inc.

BRIDGEWATER, N.J.--(BUSINESS WIRE)--Cosette Pharmaceuticals, Inc., a U.S.-based, fully integrated pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Cosette’s Abbreviated New Drug Application (ANDA) for the first generic version of CIPRO® HC (ciprofloxacin 0.2% HCl and hydrocortisone 1% otic suspension), with 180 days of Competitive Generic Therapy (CGT) exclusivity. Cosette has commenced commercial shipments, triggering the 180 days of market exclusivity. As the first approved generic of CIPRO® HC (ciprofloxacin 0.2% HCl and hydrocortisone 1% otic suspension) in more than 27 years, this launch provides patients and healthcare providers with a clinically equivalent, more affordable treatment option for acute otitis externa. “We are proud to deliver the first approved generic version of this important therapy under the FDA’s Competitive Generic Therapy pathway,” said Apurva Saraf, President and CEO of Cosette Pharma. “This is Cosette’s fourth CGT approval and launch in the last three years, demonstrating our strong R&D and operational capabilities, and our unwavering commitment to expanding patient access to needed medicines. We will manufacture this product at our state-of-the-art manufacturing facility in Lincolnton, North Carolina, and will continue to advance our pipeline to address critical gaps in treatment availability for patients.” According to IQVIA™, U.S. annual sales of CIPRO® HC for the 12 months ending September 2025, were approximately $17.9 million. CIPRO® is registered trademark of Bayer Intellectual Property GmbH, licensed to Alcon by Bayer Intellectual Property AG. See Package Insert (PI) for full prescribing information including Safety Information here. About Cosette Pharmaceuticals Cosette Pharmaceuticals, Inc. is a U.S.-based, fully integrated pharmaceutical company with a fast-growing portfolio of products in women’s health and dermatology. Cosette has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories. Cosette has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by 350+ dedicated team members across all functional areas. Cosette is backed by Avista Healthcare Partners, a healthcare focused private equity firm, and funds managed by Hamilton Lane, a private markets investment management firm (Nasdaq: HLNE). For more information, please visit www.cosettepharma.com or follow Cosette on LinkedIn.

Plus, news about BioCryst, Cycle Pharma, Applied Therapeutics, Contineum Therapeutics, Juncell Therapeutics, Cosette and Mayne Pharma: 📊 Innovent’s mazdutide shows early promise in adolescents : The injected GLP-1/glucagon agonist allowed body weight and BMI reductions of up to 9.9% and 11%, respectively, in patients with obesity at three months. The data came from a China-based Phase 1b trial in patients aged 12 to 17, and were statistically significantly better than the 1.2% and 1.7% respective weight and BMI reductions in the placebo group. Innovent said Thursday that an approval trial in adolescent obesity would begin “soon.” Mazdutide is sold in China as Xinermei, but only for adults, and no weight-loss drugs are specifically approved for children and adolescents in China. It is licensed to Eli Lilly for Western markets. — Elizabeth Cairns 🏔️ Everest Medicines makes a deal: Everest is paying $29 million upfront to fellow Chinese biotech Hasten Biopharmaceutical for the Greater China rights to develop the PCSK9 inhibitor lerodalcibep, which was developed by US-based company LIB Therapeutics. Hasten could get up to $30 million in development and regulatory biobucks and up to $280 million in sales milestones. — Kyle LaHucik ➕ FDA expands use of BioCryst drug to kids ages 2 and up: BioCryst said Friday that the FDA greenlit the use of an oral pellet version of its hereditary angioedema drug Orladeyo to kids aged 2 and up to prevent attacks associated with the disease. The therapy was previously approved for patients 12 and older. — Lei Lei Wu 🤝 Cycle Pharma plans to buy Applied Therapeutics: The private biotech plans to buy the Nasdaq-listed rare disease drug developer for 8 cents per share $APLT and up to 40 cents per share in a series of contingent-value rights. Applied said last month it would pursue strategic alternatives . Its drug candidate govorestat was rejected by the FDA last year. Cycle tried buying Vanda Pharmaceuticals last year but was rejected . — Kyle LaHucik 💰 Contineum Therapeutics raises $90M in stock sale: The I&I and neuroscience drug developer priced its public offering at $90 million after initially announcing plans for a $75 million offering. The stock sale comes after Contineum in November said a Phase 2 multiple sclerosis trial failed, though Wall Street analysts said the news was not catastrophic for the San Diego biotech. — Lei Lei Wu ⬆️ Another biotech eyes Hong Kong listing: Juncell Therapeutics filed for an IPO on the industry’s hottest stock exchange this year. Juncell is working on multiple cancer treatments, including a tumor-infiltrating lymphocyte (TIL) candidate that will be filed for approval next year. — Kyle LaHucik 🛑 Cosette and Mayne Pharma deal ends: The companies terminated their $387 million M&A deal this week after Australia’s government said last month it would block the transaction. — Kyle LaHucik Editor’s note: This story was updated to clarify that the Orladeyo approval was for the pellet version of the drug.

Cosette Pharmaceuticals had been trying to back out of its $430 million buyout of Mayne Pharma since May, prompting a legal back-and-forth between the two companies. After months of legal attempts to get out of its $430 million buyout of Australia’s Mayne Pharma, Cosette Pharmaceuticals has received a lifeline from the Australian government.Australia’s Treasurer Jim Chalmers’ decision took the advice of Australia’s Foreign Investment Review Board (FIRB) and was based on “national interest grounds,” he said in a Nov. 21 release.“This is about doing what is necessary to protect Australia’s national interest, the security of our critical medical supply chains, local jobs and the local community,” Chalmers explained.With that, Mayne must lay to rest its fervent efforts to maintain the original deal. The company is “currently assessing its options and next steps,” it said in a notice to shareholders.New Jersey-based Cosette was hoping to become a global women’s health powerhouse when it inked a pact in February to take over all outstanding Mayne shares at AUD $7.40 per share. But buyer's remorse seemed to set in shortly afterward, as told through a series of filings Mayne issued with the Australian Stock Exchange. According to a May notice Mayne issued to its shareholders, Cosette asserted that a material adverse change had occurred on Mayne’s end, triggering obligations to “promptly consult in good faith for 10 business days.” That clause is a requirement for parties seeking to terminate a scheme implementation deed (SID), Mayne noted. An SID is the term for a binding agreement used to dictate M&A in Australia and the U.K.Cosette’s concerns seemingly began with Mayne’s financial performance and future forecasts issued to Cosette around March, according to the Australian Financial Review. Plus, a letter from the FDA noting that Mayne had made “misleading” claims about its contraceptive medication, Nextstellis, didn’t help the situation when it arrived in late April, although that matter was eventually resolved by June, Mayne would later say.Even so, Mayne attempted to wave off Cosette’s concerns and carry on with the SID, rejecting Cosette’s contention of a material change and maintaining that “there is no obligation for the parties to consult,” although it remained open to a dialogue, it said in May.By June, Cosette formally tried to terminate the deal. Once again, Mayne moved to reject the termination as “invalid” on the grounds that there was “no lawful basis” for its buyer to cancel the SID. The matter was quickly brought to the Supreme Court of New South Wales (NSW), where Cosette sought a declaration of a validly terminated SID and a fee from Mayne. Days later, Mayne’s shareholders voted in favor of the buyout, Mayne said in a later filing.Mayne ultimately won out in the courts in October, when the Supreme Court ruled that Cosette did not validly terminate its takeover deal. According to global law firm HSF Kramer, the court found that Mayne’s financial materials or its FDA letter quantified as a material adverse change, meaning that Cosette couldn’t cancel its deal. Even so, the Australian government and its Foreign Investment Review Board (FIRB) still needed to weigh in, which is where the wheels ultimately fell off after months of Mayne’s attempts to forge ahead with the deal.On Nov. 19, the Australian government’s Takeover Panel issued a release pointing to Cossette’s intentions with Mayne’s manufacturing site in Salisbury South, South Australia. According to the panel, Cosette alerted the FIRB that it intended to “dispose of or close” the Salisbury site, which constituted a “change of intentions” that wasn't previously known. Mayne got wind of this in late October, when Australia’s Treasurer warned Cosette that he was “considering” prohibiting the acquisition. Given that the original contract between Mayne and Cossette stipulated that Cosette would “continue the business and operations of Mayne Pharma largely in the same manner as it is currently operated,” Mayne sought out orders from the Australian Takeover Panel that would compel Cosette to agree to “any conditions” from the government related to the site to keep the deal afloat. As Mayne saw it, Cosette had "exhausted other avenues to avoid completing the transaction" and was left to leverage the knowledge of the "likely discomfort FIRB has with the notion of job losses and loss of manufacturing capability in Australia" to cause the agreement to fail without FIRB's approval, it said in its application with the Takeover Panel. The panel ultimately ruled that Cosette must agree to conditions required by the Treasurer in connection with the Salisbury site. Chalmers “took seriously” the final ruling from the panel, which, he notes, is independent and not governed by a national interest test.Still, the FIRB advised the Treasurer’s decision with its warning that “no conditions could be put in place to adequately mitigate national interest risks, particularly unique risks to the supply of critical medicines.”