Enough hubbub about HHS Truvada patents, Gilead says. We are challenging them at the PTO

FiercePharma | August 22, 2019

Enough hubbub about HHS Truvada patents, Gilead says. We are challenging them at the PTO
Drugmakers have often lambasted the U.S. Patent and Trademark Offices (PTOs) inter partes review system, but now Gilead Sciences is hoping to use it to its advantage. The drugmaker is taking on the U.S. government, arguing the Department of Health and Human Services patents covering preventive uses of its HIV drug Truvada are invalid. Gilead says it stronglybelieves HHS pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) patents for Truvada granted since 2015 are invalid. It's asking the PTO to review and invalidate them accordingly. The company hasn't acted on that belief until now, but Gilead says that “well before” HHS claims to have invented PrEP and PEP, “others had conceived of using an antiretroviral therapy” such as Truvada for “both forms of prophylaxis.” The company pointed to unspecified 2004 guidelines recommending combo antitretrovirals for “high risk” individuals before HIV exposure. Centers for Disease Control and Prevention guidelines in 2005 recommended Truvada for prophylaxis immediately after exposure, the company says. Government patents covering Gilead’s Truvada have made the rounds in the press lately, and the company figures the ongoing debate is “a distraction from the important work being done by Gilead and its many community partners to reduce barriers to PrEP."

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You are here: Home / Featured / 4 Reasons Why Pharma Must Use Digital to Engage Payers4 Reasons Why Pharma Must Use Digital to Engage Payers Increasing scrutiny on cost and outcomes is having an unprecedented impact on formulary decisions. As a result, marketers in pharmaceutical companies charged with engaging with payers are under more pressure than ever to stay relevant and influence formulary decision makers. See Manhattan Research’s Infographic, 4 Reasons Why Pharma Must Use Digital to Engage Payers.

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PHARMACY MARKET

Regis Expands Facilities to Support Rising Demand for U.S.-Based Custom API Pharmaceutical Development and Manufacturing

Regis | February 18, 2021

Regis Technologies, Inc. today reported the culmination of a significant extension of their laboratory facilities for the development of dynamic pharmaceutical ingredients (APIs) situated in Morton Grove, Illinois. The extension, which pairs the organization's ability to take on new development projects, is currently completely operational. It expands capacities across Regis' custom pharmaceutical service contributions, including analytical development, process chemistry, solid state chemistry, validation, stability studies, and commercialization. Regis works in serving the API development and assembling needs of medium sized and arising pharmaceutical and biotechnology organizations. Their blend of top notch, full-service CDMO contributions and individualized client consideration has energized developing demand for their services. The new lab extension activity was dispatched two years prior in light of this demand, empowering Regis to give the new limit something to do during this period of uncommon scarcity for U.S.- based exhaustive, experienced API development and assembling services. The new 9,000-square-foot development incorporates extra process chemistry and analytical research centers, a committed ICP-MS suite, extra environment controlled capacity, 14 extra smoke hoods, a few new kilo-scale reactors, and process security hardware for reaction calorimetry estimations to guarantee safe control and scale-up. What's more, the new labs have an advanced variable air volume (VAV) air framework for clean energy-efficient operations. “The boom in biotechnology firms developing novel small molecule drugs has contributed to our robust growth in recent years,” said Joe Miller, PhD, CTO at Regis Technologies. “We provide top quality end-to-end API development and manufacturing services for clinical-stage companies and for commercial-stage firms serving medium-sized, rare disease and other specialty markets. This focus enables us to provide a comprehensive range of services that are tailored to our customers’ individual needs.” Dr. Miller continued, “Our investment in this new capacity broadens Regis’ capabilities and our flexibility to support the growing need for U.S.-based custom pharma services. The desire to reduce supply chain risk, ensure quality, and maintain intellectual property is driving a surging interest in domestic on-boarding of API development and manufacturing. This timely expansion allows us to meet this demand, enabling our scientists to support additional API projects as our customers advance their novel drugs to market.” About Regis Regis Technologies, Inc. is a U.S.-based CDMO specializing in small molecule APIs. We offer a full range of services to support the development of our clients' lead molecules from preclinical and clinical API through commercialization, including process research and development, solid state chemistry, analytical development, stability services, GMP API manufacturing, and micronization. In addition, Regis also offers an innovative line of proprietary chromatography products sold throughout the world. Regis is privately owned and operated and has been in business in the Chicago area since 1956.

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BUSINESS INSIGHTS

Recro Announces Acquisition of San Diego-based IRISYS, Creating Bi-Coastal, Full Service CDMO

Recro Pharma, Inc. | August 16, 2021

Recro Pharma, Inc. a contract development and manufacturing organization dedicated to solving complex formulation and manufacturing challenges for companies developing oral solid dose drug products, today announced its acquisition of IRISYS, a San Diego-based CDMO that possesses capabilities that complement and expand those of Recro. Recro acquired IRISYS for approximately $50 million in a combination of cash, shares of Recro common stock and a seller promissory note. With its acquisition of IRISYS, Recro has transformed itself into a full service CDMO with operations on both the East and West Coast of the U.S. capable of offering its now expanded global client base access to services spanning from pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for wide range of dosage forms. “Today’s acquisition of IRISYS is truly a transformative transaction for Recro. The joining of these two companies creates an organization that is ideally positioned to achieve Recro’s previously disclosed four-pronged strategy for growth, which includes strengthening the organization’s leadership and talent, expanding and diversifying our client base, fortifying our financial position, and enhancing our capabilities and competencies,” said David Enloe, president and chief executive officer of Recro. “Adding the personnel, facilities, capabilities and global customer base of IRISYS advances each of these goals and positions Recro for sustainable, profitable growth moving forward. We welcome the members of the IRISYS team to the Recro family and are eager to begin implementing the integration of the companies.” IRISYS is a full service CDMO based in San Diego, CA with capabilities that range from formulation development to commercial manufacturing for various dosage forms including oral liquids, sterile injectables, tablets, topicals, liquid/powder filled capsules, ophthalmic droppers, liposomes and nano/microparticles. IRISYS serves a diverse, global client base within the biopharmaceutical industry with its nearly 40 clients located in six different countries around the world. This includes manufacturing support for four commercial and near-commercial products. Importantly, IRISYS recently added automated, aseptic fill/finish and lyophilization capabilities to its existing facility, offering a new key avenue for significant near-term growth. IRISYS expects to generate $15.4 million in revenue for full year 2021 and has approximately $23 million spanning its contracted backlog and vetted sales pipeline. Strategic Rationale Recro’s acquisition of IRISYS was driven by a number of compelling factors covering the four prongs of the company’s ongoing growth strategy. Enhances Capabilities and Competencies: Expands technical focus beyond oral solid dose to include sterile injectables oral liquids, tablets, topicals, liquid/powder filled capsules, ophthalmic droppers, liposomes and nano/microparticles; Adds new capabilities in the areas of aseptic fill/finish and lyophilization; and Establishes bi-coastal footprint from which to better serve clients within the U.S., as well as globally. Expands and Diversifies Client Base: Adds more than three dozen clients spanning six countries, reducing Recro’s customer dependency risk; Provides greater balance between our clinical and commercial project mix; and Diversifies portfolio from exclusively oral solid dose to a balance of multiple advanced dosage forms and oral solid dose. Fortifies Financial Position: Adds profitable business with IRISYS full year 2021 estimated revenues of $15.4 million, net income of $2.1 million and EBITDA* of $2.8 million; the corresponding anticipated improvement in Recro’s EBITDA will be beneficial to Recro’s debt covenants under its credit agreement. Recro intends to provide updated financial guidance when it releases third quarter 2021 earnings; Offers significant revenue diversification, reducing financial reliance on any particular client or service offering; Becomes accretive by the fourth quarter of 2021, excluding integration costs; and Enables transaction-related paydown of credit facility and an extension of the due date, leading to improved cash flow. In addition to the advancement of the company’s four-pronged growth strategy, the acquisition was also driven by key synergies between Recro and IRISYS within business development, clinical development and commercial scale-up, as well as a strong cultural alignment and fit between the companies. Transaction Details Under terms of the agreement, Recro has acquired 100% of the equity interests of IRISYS in exchange for consideration having an aggregate value of approximately $49.850 million. The purchase price was paid through: (i) $25.5 million of cash at closing; (ii) 9,302,718 shares of common stock of Recro to be issued in six months; and (iii) a seller promissory note of $6.1 million. The seller note has a three (3) year maturity date from the date of closing and bears interest at a rate of 6% annually. The seller note is expressly subordinated and unsecured in right of payment and priority to Recro’s existing debt with Athyrium Capital Management. Bailey Southwell & Co. served as the exclusive financial advisor to IRISYS. William Blair & Company, L.L.C. represented Recro on the transaction. Non-GAAP Financial Measures Certain financial measures of IRISYS presented in this press release, including EBITDA, were not calculated using U.S. generally accepted accounting principles (“GAAP”). We believe these financial measures are helpful in understanding IRISYS’ business because it allows for greater transparency of supplemental information used by Recro’s management in connection with the acquisition of IRISYS. These measures are used by investors, as well as Recro’s management, in assessing IRISYS’ past and potential future performance. Non-GAAP financial measures should be considered in addition to, but not as a substitute for, reported GAAP results. Further, Non-GAAP financial measures, even if similarly titled, may not be calculated in the same manner by all companies, and therefore should not be compared. Please see the section of this press release titled “IRISYS, LLC Reconciliation of GAAP to Non-GAAP Financial Measures” for a reconciliation of Non-GAAP EBITDA, to its most directly comparable GAAP measure. About Recro Recro is a contract development and manufacturing organization with capabilities from early feasibility to commercial manufacturing. With an expertise in solving complex manufacturing problems, Recro is a CDMO providing oral solid dosage form development, end-to-end regulatory support, clinical and commercial manufacturing, and packaging and logistics services to the global pharmaceutical market. In addition to our experience in handling DEA controlled substances and developing and manufacturing modified release oral solid dosage forms, Recro has the expertise to deliver on our clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. We do all of this in our best-in-class facilities, which total 120,000 square feet, in Gainesville, Georgia.

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RESEARCH

Nanoform Releases Next-Generation AI-based Drug selection Tool

Nanoform | March 23, 2021

Nanoform innovative nanoparticle medicine enabling company next generation of its STARMAP® AI artificial intelligence platform nanoparticle bioavailability excipient microns nm CESS technology silico pharma drugs lifecycle managementNanoform, an innovative nanoparticle medicine enabling company, has today dispatched the next generation of its STARMAP® AI (artificial intelligence) platform, v2.0. The technology uses scanty information AI to expand trial results from its CESS® nanoparticle designing process with detailed master information, permitting dependable expectations to be made in regards to accomplices' likely success of nanoforming their medication atoms. CESS® is a nanoparticle platform technology which produces unadulterated homogeneous medication particles from arrangement in a without excipient process. By diminishing the molecule size e.g., from 10 microns to 50 nm, the particular surface territory can be expanded by as much as 1000-crease, subsequently improving disintegration rate, solvency, and bioavailability. Subsequently, Nanoform can help pharma accomplices progress atoms into advancement that in any case might not have been conceivable. It additionally opens up energizing opportunities for a wide scope of novel medication conveyance applications. STARMAP® is a computerized form of the CESS® technology that empowers in silico tries in enormous amounts, making quick forecasts of which atoms ought to be nanoformed. This is significant since there are more potential medication atoms than particles in the known universe. STARMAP® can be a useful asset for pharma accomplices to pick appropriate medication contender for additional improvement from their huge libraries. The benefits may incorporate quicker way to advertise and additional opportunities for widening and extending drug pipelines while at the same time expanding the likelihood of medication improvement success. The STARMAP® platform can have wide materialness in drug disclosure and advancement just as in lifecycle management for existing promoted drugs and 505b2-like item improvement methodologies. "AI algorithms developed for big data have so far struggled to live up to expectations in pharma because the data, especially for early assets (drug discovery, drug screening), that is available to pharma is typically insufficient for generating reliable predictions. We believe sparse-data AI will work much better - in practice, this means augmenting experimental results with detailed expert knowledge, which can be used to prevent the AI from predicting outcomes that are nonsensical based on prior understanding. There is a lot of untapped potential in sparse-data AI for the pharma industry and the field continues to undergo rapid development in both academia and the industry in general," said Prof. Jukka Corander, Head of AI at Nanoform. "By determining which drug candidates are ideal for our CESS® process, the next-gen STARMAP® platform can potentially create new opportunities for our pharma partners. These can include both revisiting drug candidates unnecessarily discarded by AIs trained on old particle engineering techniques, and rapidly picking winners among new drug candidates. Ultimately, the benefit of more advanced AI will be felt by patients as new therapies are accelerated to market," commented Christian Jones, Chief Commercial Officer at Nanoform

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You are here: Home / Featured / 4 Reasons Why Pharma Must Use Digital to Engage Payers4 Reasons Why Pharma Must Use Digital to Engage Payers Increasing scrutiny on cost and outcomes is having an unprecedented impact on formulary decisions. As a result, marketers in pharmaceutical companies charged with engaging with payers are under more pressure than ever to stay relevant and influence formulary decision makers. See Manhattan Research’s Infographic, 4 Reasons Why Pharma Must Use Digital to Engage Payers.