Takeda recalls eye drug Natpara but warns patients not to abruptly stop treatment

FiercePharma | September 06, 2019

Takeda Pharmaceutical’s been looking for a buyer for Natpara to provide some debt relief, but it has just run into some complicating circumstances. It is having to recall the eye drug from the market, a move it says may be very challenging for patients. Takeda today announced it was voluntarily recalling all doses of the injected drug in the U.S. because there was a chance of small rubber particles shedding into the injectors. But the Japanese drugmaker was adamant that patients mustn’t stop the treatment abruptly because of the danger of a sudden drop in blood calcium levels. Instead, patients must have their doctor replace the drug with supplements and carefully monitor their calcium levels with blood tests. “It is critically important that patients contact their prescribing healthcare provider to discuss their individual treatment plan and ensure close supervision including frequent monitoring of blood calcium levels and close titration of active vitamin D and calcium supplements upon stopping Natpara to avoid low blood calcium (hypocalcemia),” the company said.

Spotlight

Drug development is an area of high risk, but it also has potential to be of high reward. Developers can create therapeutics that have an enormously positive impact on outcomes for patients, reduce the burden on healthcare and create return on investment for shareholders. But those same therapeutics face ever-increasing development costs, and there are many potential pitfalls between identifying a hit and mass production. Meanwhile, the demand for new treatments place ever more pressure on the industry to succeed.

Spotlight

Drug development is an area of high risk, but it also has potential to be of high reward. Developers can create therapeutics that have an enormously positive impact on outcomes for patients, reduce the burden on healthcare and create return on investment for shareholders. But those same therapeutics face ever-increasing development costs, and there are many potential pitfalls between identifying a hit and mass production. Meanwhile, the demand for new treatments place ever more pressure on the industry to succeed.

Related News

PRACTICE MANAGEMENT

Royalty Pharma Acquires Royalty Interest in ORLADEYO and BCX9930 From BioCryst Pharmaceuticals

Royalty Pharma | December 08, 2020

Royalty Pharma, BioCryst Pharmaceuticals, Inc. what's more, Athyrium Capital Management, LP today declared exchanges adding up to $325 million in financing for BioCryst, with $250 million accessible at shutting, to help the dispatch of ORLADEYO™ (berotralstat) in genetic angioedema (HAE) and the advancement of its oral Factor D inhibitor, BCX9930. Royalty Pharma will furnish BioCryst with a forthright money installment of $125 million and will get eminences of 8.75% on direct yearly net deals of ORLADEYO up to $350 million, 2.75% on deals between $350 million and $550 million, no royalty on deals over $550 million, and a layered level of sublicense income for ORLADEYO in specific domains. Likewise, Royalty Pharma will get a 1.0% royalty on worldwide net deals of BCX9930, whenever affirmed. An asset oversaw by Athyrium Capital Management will give BioCryst a $200 million credit office, of which BioCryst will draw $125 million at shutting. The extra capital will be accessible in two tranches at BioCryst's alternative, after arriving at characterized income achievements. The credit office bears revenue at LIBOR +8.25% (with a LIBOR floor of 1.75%) and is revenue just for the whole five-year term, with all extraordinary head due at development. Also, BioCryst has the choice to pay revenue in-kind for the initial eight fourth of the term, permitting the organization to concede money premium installments until after this period. The organization will be dependent upon a base liquidity contract of $15 million. There are no other monetary agreements except if the third tranche is drawn by BioCryst. BioCryst plans to contribute the joined continues to help the dispatch of ORLADEYO in the U.S. what's more, Europe and to propel the advancement of BCX9930 into clinical preliminaries in various supplement intervened sicknesses. Also, BioCryst will reimburse its current office with MidCap Financial. "We trust ORLADEYO will be a groundbreaking medication and we are eager to cooperate with BioCryst to bring this oral, once-every day medication to HAE patients. In view of the empowering verification of idea information in paroxysmal nighttime hemoglobinuria with BCX9930, we likewise accept this oral Factor D inhibitor offers considerable open doors over different supplement interceded sicknesses," said Pablo Legorreta, Chief Executive Officer of Royalty Pharma. "With a productive R&D ability, long IP on their items and huge close term business openings, BioCryst speaks to the ideal profile Athyrium looks for our speculations and we are eager to add to the organization's future achievement," said Hondo Sen, accomplice at Athyrium Capital Management. "The generous monetary responsibility of extraordinary long haul accomplices like Royalty Pharma and Athyrium Capital Management empowers BioCryst to completely put resources into the dispatch of ORLADEYO and to quicken the advancement of BCX9930 to address a neglected requirement for patients and convey an incentive to investors. We accept the present financing mirrors the subsequent stage in the change of BioCryst," said Jon Stonehouse, Chief Executive Officer of BioCryst. Cowen went about as monetary guide to BioCryst on the exchange. Gibson Dunn went about as lawful consultant to BioCryst. Goodwin Procter, Wolf Greenfield and Maiwald went about as legitimate counsels to Royalty Pharma. Hogan Lovells went about as lawful counselor to Athyrium Capital Management.

Read More

BUSINESS INSIGHTS

Asymchem and LaNova Medicines Enter into Partnership Agreement, Expanding Biological Capabilities

Asymchem | September 17, 2021

Asymchem today announced a strategic partnership agreement to provide LaNova Medicines with one-stop services such as small molecule drugs, ADC project CMCs, R&D, production and IND China-US declaration. The collaboration between Asymchem and LaNova will include small molecule drugs, monoclonal antibodies, double antibodies, ADC projects and potentially other R&D and production initiatives. This partnership will take full advantage of Asymchem's recently completed biological CDMO service platform and production base at Shanghai Jinshan, where Asymchem is already undertaking R&D and production services for a number of early IND and clinical phase projects of biological drugs. The platform can provide R&D and production services including monoclonal antibodies, double antibodies, and ADC drugs. With the advent of the ADC drug research and development wave, ADC-related businesses have exploded, In the future, we expect to build ADC pilot and commercial production facilities to further enhance Asymchem's capabilities with ADC drugs. - Asymchem Chief Operating Officer (COO) Yang Rui, who attended the signing ceremony in Shanghai. Antibody-drug conjugates (ADCs) are a highly promising class of targeted drugs in which drug molecules are linked to antibodies that selectively attach to the surface of cancer cells while avoiding effects on nearby healthy cells, dramatically reducing side effects. More than 100 clinical trials are underway studying the effectiveness of ADCs in treating blood, lung, breast, brain and other cancers. Rui said the partnership was a logical next step for Asymchem as the CDMO continues to expand its capabilities and service into new business areas to offer pharmaceutical and biotech companies innovative and sustainable solutions. About Asymchem Founded in 1999, Asymchem stock code: 002821.SZ) is a leading global integrated Contract Development and Manufacturing Organization (CDMO) providing innovative drug R&D and manufacturing. Asymchem is supported by more than 5,000 employees based in PR China, the US, and the EU. Our mission is to drive efficiency through continuous technological advances for smarter, greener and more cost-effective manufacturing to support pharmaceutical clinical research and commercialization, backed by a proven track record of successful agency and industry inspections. About LaNova Medicines Based in Shanghai, LaNova Medicines is a clinical-stage R&D company whose primary focus is the development of macromolecular anti-tumor drugs utilizing GPCRs for monoclonal antibody production. The company's comprehensive platform capabilities include target verification, antibody engineering, production technology, preclinical and clinical research.

Read More

PHARMACY MARKET

Arrowhead Pharmaceuticals Initiates Phase 1/2 Study of ARO-C3 for Treatment of Complement Mediated Diseases

Arrowhead Pharmaceuticals Inc. | February 19, 2022

Arrowhead Pharmaceuticals Inc. announced that it has dosed the first subjects in AROC3-1001, a Phase 1/2 clinical study of ARO-C3, the company’s investigational RNA interference (RNAi) therapeutic designed to reduce production of complement component 3 (C3) as a potential therapy for various complement mediated diseases. “We believe a C3 targeted drug has the potential to address multiple complement mediated and complement associated diseases, where significant unmet medical need exists. These include IgA nephropathy, C3 glomerulopathy, paroxysmal nocturnal hemoglobinuria, and additional renal and hematologic diseases that we intend to evaluate in the future. ARO-C3 has progressed rapidly, and our preclinical data have been very encouraging. We are eager to continue this progress as we evaluate ARO-C3 in clinical studies.” James Hamilton, M.D., MBA, senior vice president of discovery and translational medicine at Arrowhead AROC3-1001 is a Phase 1/2, placebo controlled, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-C3 in up to 24 adult healthy volunteers, up to 24 adult patients with paroxysmal nocturnal hemoglobinuria (PNH), and up to 14 adult patients with complement-mediated renal disease. In Part 1 in healthy volunteers, four cohorts with four escalating dose levels of ARO-C3 will be evaluated. Each cohort will enroll 6 eligible subjects who will be randomized to receive a single subcutaneous injection of ARO-C3 (n=4) or placebo (n=2). In Part 2, eligible subjects with PNH or complement-mediated renal disease will be enrolled to receive open-label ARO-C3 on day 1 and day 85 at one of two dose levels to be determined in Part 1. The primary objective of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of ARO-C3 in normal healthy volunteers and to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of ARO-C3 in subjects with PNH and in subjects with complement-mediated renal disease. About Arrowhead Pharmaceuticals Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

Read More