17 December 2019

Charles River Laboratories to acquire HemaCare for $380m

Charles River Laboratories International has signed a definitive agreement to acquire cellular products developer HemaCare for a cash consideration of approximately $380m.

HemaCare manufactures human-derived cellular products for use in cell therapies.

In addition to biomaterials supply, the company provides processing services to discover, develop and manufacture cell therapies, including allogeneic and autologous candidates.

HemaCare is expected to complement Charles River’s discovery, safety assessment and manufacturing support services. Charles River intends to leverage the deal to help cell therapy developers and manufacturers speed-up their cell therapy programmes.

The combination of the companies’ will create a cell therapy solution that will aid from discovery through commercialisation.

Charles River Laboratories chairman, president and CEO James Foster said: “In order to continue to enhance our ability to support our clients’ research efforts, particularly in biologics discovery and development, we are expanding our scientific capabilities in this emerging, high-growth market with the acquisition of HemaCare.

“The addition of HemaCare’s innovative cell therapy products and services to our integrated, early-stage solutions will create a unique, go-to partner for clients to work with Charles River across a comprehensive cell therapy portfolio from idea to novel therapeutic.”

HemaCare will expand its high-growth cell therapy solutions, which contribute nearly $100m to its annual revenue, added Charles River.

Furthermore, the growth of cell therapy market is expected to increase the addressable market for HemaCare’s products from the current $200m to approximately $2bn by 2030.

HemaCare president and CEO Pete van der Wal said: “Partnering with Charles River will strengthen the value proposition for our clients, enabling them to work seamlessly with one scientific partner to enhance the speed and efficiency with which they can advance their cell therapies. The transaction will offer compelling value to our shareholders.”

The board of directors of both the companies have approved the acquisition, along with some of HemaCare’s directors, officers and shareholders.

However, the deal remains subject to regulatory approvals and other customary closing conditions, set to close in the first quarter of next year.

16 December 2019

FDA approves Amarin’s Vascepa to reduce CV risk in heavily treated patients

The US Food and Drug Administration (FDA) has approved a label expansion for Amarin’s Vascepa (icosapent ethyl) based on its efficacy in reducing the risk of cardiovascular (CV) events in patients already treated with various cholesterol lowering therapies.

The new indication for Vascepa is as an adjunct to maximally tolerated statin therapy to decrease the risk of various CV events, such as heart attacks, stroke, unstable angina and coronary revascularization.

The drug is indicated for patients with elevated triglyceride levels, established CV disease or diabetes, and at least two additional risk factors for CV disease. Vascepa is the first and only drug approved for this indication, said Amarin.

The FDA originally approved Vascepa in 2013 alongside dietary changes to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.

Amarin CEO and president John F. Thero said: “We at Amarin are excited and gratified to now have the opportunity to introduce Vascepa as a new FDA-approved treatment option to reduce the persistent cardiovascular risk that many patients face despite use of statins with other contemporary standard-of-care therapies.

“For the first time, physicians, patients and payers have an FDA-approved treatment option beyond cholesterol lowering that has been demonstrated to significantly reduce major adverse cardiovascular events when used on top of a statin.”

The FDA’s decision was based upon the results of the REDUCE-IT study studying Vascepa’s effect on the time to the first occurrence of CV events. Approximately 22% of patients in the control arm who were treated with statins or other cholesterol lowering therapy, but not Vascepa experienced a major adverse CV event (MACE), defined as stroke, heart attack, coronary revascularization, unstable angina hospitalisation and CV death – only 17.2% of the Vascepa arm experienced a five-point MACE.

The results showed that 14.8% of the control had a three-point MACE of CV death, heart attack or stroke, compared to 11.2% for the drug group. Across all the single MACE secondary endpoints, the incidence rate was lower in the Vascepa group than the control arm.

Lead investigator of the REDUCE-IT study, professor of medicine at Harvard Medical School and executive director of Brigham and Women’s Hospital’s Interventional Cardiovascular Programs Deepak L. Bhatt said “The FDA approval of icosapent ethyl as an addition to statin therapy to reduce the risk of cardiovascular events is a major milestone in cardiovascular prevention.

“Nothing this significant has happened in the world of cardiovascular prevention since the introduction of statins nearly three decades ago. Many patients stand to benefit from this historic advance in care.”

As a result of this approval, Amarin has adjusted its revenue guidance for 2019 from a range of $380m-$420m to $410m-$425m.

16 December 2019

ViiV Healthcare seeks approval for child-friendly HIV treatment

ViiV Healthcare has submitted applications seeking approval from US and European regulators for a 5mg dispersible-tablet (DT) formulation of its dolutegravir (DTG) drug to treat children with human immunodeficiency virus (HIV) infection.

The company is also seeking the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) authorisations for simplified dosing regimen intended to enable child-friendly use of the existing 50mg DTG film-coated tablet (FCT).

DTG is an integrase strand transfer inhibitor (INSTI) that binds to the integrase active site, blocking the strand transfer step in retroviral deoxyribonucleic acid (DNA) integration required for HIV replication.

The drug is indicated for use in combination with antiretroviral (ARV) agents to treat HIV. If approved, the dispersible tablet formulation of DTG will be the first-of-its-kind accessible for paediatric patients.

ViiV Healthcare CEO Deborah Waterhouse said: “For parents living in resource-poor countries, the ability to give medicine to children in a format that they can swallow and tolerate can mean the difference between life and death.

“By submitting these files to regulators for approval, we believe that we are on the cusp of delivering against our promise to develop dolutegravir in a tablet that can be dispersed simply in water. We will then aim to make this available, via partnerships, as quickly as possible to children living with HIV worldwide.”

Regulatory applications include results from ongoing P1093 and ODYSSEY (PENTA20) clinical trials conducted in patients aged four weeks to 18 years.

P1093 involves sites in the US, South Africa, Brazil, Zimbabwe, Thailand and Malawi, while ODYSSEY is occurring in Europe, Thailand, South Africa, Uganda, South America and Zimbabwe.

Through a voluntary licensing policy, ViiV allows companies to produce and sell generics of paediatric DTG royalty-free in least-developed, low-income, lower-middle-income and sub-Saharan African countries. The licence is also applicable in some upper-middle-income countries.

13 December 2019

Amgen-UCB’s Evenity receives EC approval to treat osteoporosis

Amgen and UCB have received the European Commission (EC) approval for Evenity (romosozumab) to treat severe osteoporosis in postmenopausal women at high fracture risk.

Evenity is a bone-building medicine designed to improve bone formation and decrease bone resorption or loss, being jointly developed by Amgen and UCB.

The drug secured a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in October.

One in three women and one in five men aged above 50 years will suffer an osteoporosis-related fragility fracture and numbers are predicted to grow in the future.

Evenity is said to be the first drug approved to treat osteoporosis in the European Union (EU) since 2010.

UCB executive vice-president Dr Pascale Richetta said: “Today’s European population is living longer and expecting more out of life in their later years. Yet fragility fractures due to osteoporosis affect one in three women aged over 50 and evidence shows that many women remain undiagnosed and untreated following a fracture.

“With today’s approval of Evenity we can now offer patients and clinicians a new medicine that can help drive positive changes in secondary fracture prevention.”

Amgen and UCB plan to initially launch the drug in the European Economic Area (EEA) in the first half of next year.

The drug’s development programme includes 19 clinical trials performed in a total of about 14,000 patients.

Its ability to cut the risk of fractures was evaluated in an extensive global Phase III programme comprising two fracture studies comparing either placebo or active comparator in approximately 11,000 postmenopausal women with osteoporosis.

The drug obtained the US Food and Drug Administration (FDA) approval to treat postmenopausal osteoporosis in women at high risk for fracture in April.

12 December 2019

Data shows non-inferiority of SC administration of Roche’s Perjeta and Herceptin

Roche has published data demonstrating non-inferiority of a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) administered through subcutaneous (SC) injection to standard intravenous (IV) infusions of the two drugs in HER2-positive early breast cancer.

The SC fixed-dose combination of the two drugs combined with IV chemotherapy met its primary endpoint in the global, multicentre Phase III FeDeriCa study of non-inferior levels of Perjeta in the blood.

The SC combination also met two secondary endpoints of non-inferior levels of Herceptin in the blood and comparable pathological complete response. The safety profile between the two administration routes were also similar.

Previous studies have shown that the SC administration route is strongly preferred by patients; it only takes around eight minutes for the initial loading dose and then approximately five minutes per each maintenance dose, compared to 150 minutes for the initial IV infusion and then 60 to 150 minutes for future doses.

Combining Perjeta with IV Herceptin and chemotherapy is approved in more than 100 countries for the treatment of both early and metastatic HER2-positive breast cancer. The two drugs are believed to have complementary mechanisms of action against the HER2 receptor.

Roche chief medical officer and head of global product development Levi Garraway said: “This fixed-dose subcutaneous combination has the potential to provide a quicker and less invasive method of administration for people with HER2-positive breast cancer being treated with Perjeta and Herceptin.

“This is the first time that we have brought together two of our targeted antibodies as a single subcutaneous injection that can be administered in just minutes.”

The SC administration approach for Perjeta and Herceptin is developed using Halozyme Therapeutics’ Enhanze drug delivery technology; the two companies have been collaborating around the technology since 2006.

The Enhanze platform relies upon a proprietary recombinant human hyaluronidase PH20 enzyme that degrades hyaluronan, which is a chain of natural sugars, to support the dispersion and absorption of injected drugs.

12 December 2019

Almirall signs deal for Iktos’ AI technology in drug design

Spanish pharmaceutical firm Almirall has agreed with Iktos to leverage the latter’s generative modelling artificial intelligence (AI) technology to design novel drugs.

Almirall will use AI technology to optimise compounds and identify promising therapeutic candidates for one of its drug discovery programme. The company did not disclose specific details about the programme.

With a focus on skin health, the company’s pipeline includes candidates in development to treat actinic keratosis, androgenic alopecia, onychomycosis and atopic dermatitis.

The company expects the digital approach to help discover molecules and accelerate clinical development.

Almirall chief scientific officer and R&D executive vice-president Dr Bhushan Hardas said: “The health sector lags behind others in the digital world. Almirall wants to be at the forefront of innovation to develop holistic and transversal approaches.

“Artificial intelligence will provide Almirall a unique opportunity to combine our proficiency with the preciseness and agility to truly make a difference in patients’ lives.”

Iktos’ AI technology builds on deep generative models. It is said to facilitate rapid and efficient drug discovery process via the automatic design of virtual new molecules with potential as a drug candidate.

Along with the identification of molecules, the technology is designed to analyse various bioactive characteristics and drug-like criteria for clinical testing.

Iktos president and CEO Yann Gaston-Mathé said: “We are eager to demonstrate to our collaborators the power of Iktos technology to accelerate their research, and to get the opportunity to further improve by confronting our approach to a new use case, consistently with our strategy to prove our value in real-life projects.”

Iktos’ AI technology is part of multiple biopharmaceutical alliances focused on drug design. In April, Janssen signed an agreement to use AI technology to speed up the discovery of small molecule drugs.

11 December 2019

Sanofi and Regeneron to simplify antibody partnership

Sanofi and Regeneron Pharmaceuticals have said the companies may transform their antibody partnership, which involves Kevzara (sarilumab) and Praluent (alirocumab) drugs, into a royalty-based agreement.

The restructured alliance will potentially provide Sanofi with exclusive rights to Kevzara worldwide and exclusive rights to Praluent in markets outside of the US.

Under an arrangement, Regeneron will obtain sole rights to Praluent in the US. The companies will have to fund the development and commercialisation activities in their respective territories alone.

Sanofi and Regeneron said that these changes to the antibody partnership are meant to enhance efficiency and optimise operations for the products.

The partners expect to finalise the proposed antibody agreement in the first quarter of next year. Meanwhile, the ongoing alliance for Dupixent (dupilumab) will not undergo any revisions.

Sanofi initially partnered with Regeneron in November 2007 for the discovery, development and commercialisation of fully-human therapeutic antibodies.

As part of the collaboration, Sanofi gained about 19% ownership in Regeneron.

Sanofi also received the exclusive option to co-develop each drug candidate resulting from the alliance.

The partners agreed to share development costs, with Sanofi responsible for development costs and Regeneron reimbursing 50% of the costs from its share of profits.

In January, Sanofi and Regeneron also reformed their immuno-oncology discovery and development agreement signed in 2015.

The restructured deal allows the companies to co-develop two clinical-stage bispecific antibody programmes, BCMAxCD3 and MUC16xCD3.

Sanofi announced the plans to revise its antibody partnership with Regeneron after its CEO Paul Hudson unveiled a new growth strategy.

The French pharmaceutical giant will restructure into three core global business divisions, Specialty Care, Vaccines and General Medicines. Its Consumer Healthcare unit is set to operate as a standalone entity.

11 December 2019

Flagship Pioneering launches Cellarity for cell behaviour drugs

Flagship Pioneering has launched a new company, Cellarity, to discover drugs based on insights from research of cellular behaviours.

The company was established in 2017, developing a platform that uses single-cell technologies and machine learning to analyse cell behaviour.

After digitising and quantifying cell behaviours, the platform understands the dynamics associated with those behaviours, using the information to develop therapies that can direct them.

Cellarity builds on the concept that several diseases occur due to abnormal cell behaviours in a tissue.

The company leverages this concept to quantitatively define changes in cellular behaviours related to disease and identify therapies that can restore their normal state, said Flagship.

Flagship Pioneering CEO Noubar Afeyan said: “For years, our Flagship Labs team appreciated that biological processes and diseases operate at the level of networks, and they, therefore, explored better ways to characterise disease and discover effective drugs. Recent AI and biology advances allow us to investigate this question in unprecedented ways.

“Cellarity has shown that not only can we embrace this complexity, but in fact we can also harness it to enable direct lead and drug generation, obviating the need for random screening paradigms.”

Flagship added that information on cellular behaviours enables discovery of drugs that can concurrently act on molecular, cellular, phenotypic, organismal and clinical factors of a disease, instead of only a single target protein or pathway.

The Cellarity platform features a combination of the company’s physical laboratory and its digital technology, Cellarium.

Cellarium charts biological links to cell behaviour screening generated by artificial intelligence (AI) to detect and assess therapeutic hypotheses.

By evaluating these hypotheses in animal models, Cellarity is working to advance various programmes to the clinic.

Cellarity chief digital and data officer Milind Kamkolkar noted: “Cellarity is the first therapeutics company taking a deliberate approach to leveraging AI as part of a non-hierarchical and interdisciplinary approach to drug development, rather than classically trying to apply new technologies to existing processes and siloed data sets.”

Kamkolkar joined the company with experience from Sanofi and Novartis.

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