Shire Orphan Therapies GmbH

Pharvaris will “conduct a 26-week rodent toxicology study” after last year's U.S. trial holds. Pharvaris is looking for redemption for its leading hereditary angioedema (HAE) drug hopeful PHA121 in the form of a six-month animal toxicity trial aimed at assuaging concerns over the med’s safety. In August last year, Pharvaris’ shares plummeted when the FDA slapped multiple clinical holds on phase 1 trials for the company’s HAE asset. A the time, the European biotech was mum on exactly what caused the holds, but in its business update today during the J.P. Morgan Healthcare Conference, it looks like safety was the concern. Pharvaris said in its company update Monday that it will “conduct a 26-week rodent toxicology study” with the specific aim being to “resolve the clinical holds in the U.S.” Specifics on what toxicities the company is looking for were not provided. Pharvaris adds that the protocol for this nonclinical study “has been submitted to the FDA for review.” The drug is not entirely new and Pharvaris is essentially trying to tinker and renovate an existing drug. Modeled after Jerini's HAE med Firazyr, Pharvaris hopes its small-molecule-based meds can act faster than the competition.

PRINCETON, N.J., Jan. 28, 2021 /PRNewswire/ -- Sandoz, a global leader in generic and biosimilar medicines, today announced the US launch of generic Icatibant injection pre-filled syringe to treat acute attacks of rare disease hereditary angioedema (HAE) in adults 18 years and older.1 It is available immediately for US patients. Sandoz has signed a US commercialization deal with Slayback Pharma, a company focused on producing complex generic and specialty pharmaceutical products, for this medicine, which is a generic equivalent to Takeda's Firazyr®* (icatibant injection). "We are eager to see the positive effects of making generic Icatibant available immediately to people living with this painful and disabling rare disease," said Keren Haruvi, President, Sandoz Inc. "This collaboration aligns with our goal to build our injectables portfolio and provide US patients access to affordable generic medicines that work the same as brand-name products." Hereditary angioedema is a rare disease characterized by recurrent episodes of severe swelling of the skin and mucous membranes. Swelling of the airways and throat can be extremely dangerous and potentially lead to death. Patients can also suffer nausea, vomiting, diarrhea and abdominal pain.2 "With our strong developmental capabilities and Sandoz's industry-leading commercialization of its extensive portfolio of generic medicines, we couldn't be more excited to collaborate with Sandoz and help people living with hereditary angioedema," said Ted Smolenski, Vice President of Business Development at Slayback Pharma. Slayback Pharma is a pharmaceutical company focused on the development and commercialization of complex generic and specialty pharmaceutical products, with a team of 90 employees and operations in the US and India. Slayback has a proven track record of numerous sole first-to- 505(b)(2)s and complex generic filings, approvals and commercial launches. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Laryngeal attacks: Following treatment of laryngeal attacks with icatibant injection, advise patients to seek immediate medical attention. ADVERSE REACTIONS The most commonly reported adverse reactions were injection site reactions, which occurred in almost all patients (97%) in clinical trials. Other common adverse reactions occurring in greater than 1% of patients included pyrexia, transaminase increase, dizziness, and rash. DRUG INTERACTIONS Icatibant injection is a bradykinin B2 receptor antagonist and thereby has the potential to have a pharmacodynamic interaction with ACE inhibitors where icatibant injection may attenuate the antihypertensive effect of ACE inhibitors. USE IN SPECIFIC POPULATIONS Elderly patients demonstrate increased systemic exposure to icatibant. Differences in efficacy and safety between elderly and younger patients have not been identified. Please see full Prescribing Information for additional safety information. INDICATION Icatibant injection is a bradykinin B2 receptor antagonist indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product's label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Sandoz Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical need. Our ambition is to be the world's leading and most valued generics company. Our broad portfolio of high-quality medicines, covering all major therapeutic areas, accounted for 2019 sales of USD 9.7 billion. Sandoz on social media LinkedIn: Twitter: Facebook: Instagram: CEO Richard Saynor on LinkedIn: * Firazyr® is a registered trademark of Shire Orphan Therapies GmbH, a Takeda Company. References Icatibant Injection. Prescribing Information. Available at: . Accessed November 18, 2020. National Center for Advancing Translational Sciences. Hereditary Angioedema. Available at: . Accessed October 29, 2020. National Organization for Rare Diseases. Hereditary Angioedema. Available at: . Accessed October 29, 2020.