SOURCE: LifeSci Advisors

LifeSci Advisors

February 01, 2012 11:00 ET

LifeSci Advisors Announces Investment Opinion on Repligen Corporation

Report Cites Potential of Novozymes Biopharma Acquisition to Double Revenue; NDA Submitted for SecreFlo™ for Pancreatic Imaging; Available for Download at www.lifesciadvisors.com/clients/repligen/

NEW YORK, NY--(Marketwire - Feb 1, 2012) - LifeSci Advisors, LLC, a leading provider of investment research and investor relations services in the healthcare sector, today announced that it has initiated coverage of Repligen Corporation (NASDAQ: RGEN), a leading supplier of critical products used to manufacture biologic drugs, especially monoclonal antibodies. The Company recently completed its purchase of Novozymes Biopharma Sweden AB, making Repligen the leading global supplier of Protein A affinity ligands. Repligen is preparing to introduce an expanded Opus™ line of pre-packed, single-use, plastic chromatography columns for purifying biological pharmaceuticals. Additionally, the Company is developing SecreFlo™ (RG1068, synthetic human secretin) to improve detection of structural abnormalities of the pancreatic ducts during MRI procedures. Repligen filed a new drug application (NDA) for SecreFlo™ in this indication in December 2011.

"Repligen's recent purchase of the biomanufacturing assets from Novozymes is a significant step towards profitability. The acquisition solidifies Repligen's position as a leading supplier of biomanufacturing products, and the dominant player in the Protein A market," said Andrew I. McDonald, Ph.D., Managing Director at LifeSci Advisors. "Repligen has a solid plan in place to double its bioprocessing product revenue and advance its operations toward profitability. The new Opus™ line of pre-packed chromatography products fills an important unmet need in the purification of complex biological pharmaceuticals. In addition, Repligen is advancing SecreFlo™, a synthetic hormone that in a pivotal clinical study, significantly improved the detection of abnormalities during MRI of the pancreas. This drug addresses a potential market opportunity of $100 million in the initial pancreatitis indication."

In a 28-page Initiation Report by LifeSci Advisors, the details of Repligen's recent acquisition and expanding bioprocessing business, as well as the clinical profile for SecreFlo™ and other earlier stage pipeline products, are explained. In December 2011, Repligen closed the acquisition of a suite of bioprocessing products and a manufacturing facility from Novozymes for 17 million euros ($22.7 million) plus up to 4 million euros in potential future milestone payments. In addition to Protein A affinity ligands, Repligen also acquired Novozymes' cell culture or growth factor products, whose use increases quality and yield of biologics produced in mammalian cell culture. The acquisition should double Repligen's product revenue and we expect these new products to contribute to Repligen's future growth and profitability.

Opus™ chromatography products are pre-packed, single-use, plastic chromatography columns for purifying biological pharmaceuticals such as monoclonal antibodies. Single-use, plastic products are revolutionizing the production of biopharmaceuticals and vaccines as they significantly decrease operating expenses by reducing production time and increasing facility flexibility. The columns come pre-packed with any media according to the customer's specifications. The columns are highly scalable, economical, and readily integrated into existing biomanufacturing processes. This month, Repligen will launch a larger scale Opus™ product line, suitable for the production of clinical trial material and niche commercial products such as orphan biologics. The Opus™ product line is well positioned to address customer's needs for single-use chromatography columns and has the potential to address a market opportunity of $100 million per year.

In addition to its growing bioprocessing business, Repligen is developing SecreFlo™ for improving the detection of structural abnormalities of the pancreatic ducts during MRI procedures. In a pivotal Phase 3 trial, SecreFlo™ achieved highly statistically significant efficacy results and the compound was found to be safe and well tolerated. Three radiologists assigned to compare MRI images taken before and after SecreFlo™ administration all achieved highly statistically significant improvements in sensitivity (p < 0.0001 for all three) with minimal loss in specificity. In addition, the results of the secondary endpoints were highly statistically significant including improvement in diagnostic confidence, which will be a key benefit of the drug. According to averaged data from three radiologists released by the Company, diagnostic confidence levels of 'High' or 'Very High' were reported for 23% of un-enhanced images and 70% of SecreFlo-enhanced images, a greater than 200% improvement. SecreFlo™ has previously been granted both Fast Track and Orphan Drug designations. FDA feedback on the SecreFlo™ NDA filed in December 2011 is expected during this month. This feedback will determine the NDA's acceptance for full review on either a standard (10-month) or priority (6-month) review basis.

According to the Organization for Economic Cooperation and Development (OECD) health statistics and LifeSci Advisors estimates, there are approximately 300,000 MRIs performed in the US and EU each year that could benefit from the addition of SecreFlo™. SecreFlo™ has the potential to address a $100 million market opportunity in pancreatitis in the U.S. and EU. Radiologists, who will make the decision to prescribe SecreFlo™, may have incentive to use the drug because it will lead to better outcomes for patients. Hospitals should encourage gastroenterologists to refer patients for a SecreFlo™ MRI and radiologists to prescribe SecreFlo™ because it can lead to cost savings. Furthermore, SecreFlo™ will be reimbursed as a drug under a J-code rather than as a contrast agent subject to bundling into reimbursement for the procedure.

Dr. McDonald's full Initiation Report is available to download at no cost at the LifeSci Advisors website, www.lifesciadvisors.com. In addition to this Initiation Report, LifeSci Advisors will also provide ongoing coverage and event-based research updates on the Company as developments occur.

The LifeSci Advisors research team is led by Dr. Andrew I. McDonald, an industry veteran with more than 15 years of healthcare industry experience. Prior to co-founding LSA, Dr. McDonald was the Senior Biotechnology Analyst at Great Point Partners, a leading health care investment firm with over $500 million under management. Before Great Point, he was Co-Head of Healthcare Research and Lead Biotechnology Analyst at ThinkEquity Partners, a boutique investment banking firm focused on growth companies. Dr. McDonald holds a Ph.D. in organic chemistry from the University of California, Irvine, and, earlier in his career, worked as a medicinal chemist at both Pfizer and Cytokinetics.

About LifeSci Advisors:

LifeSci Advisors (LSA) is a leading research firm and communications consultancy dedicated to the life sciences industry. The firm provides strategic counsel, customized marketing communications, comprehensive research reports and investor relations services to companies that specialize in the discovery, development and commercialization of drugs, drug delivery systems, medical devices and diagnostics. To learn more about LSA, visit the company's website, www.lifesciadvisors.com.

Important Disclosures:

The research report described in this press release is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell securities. The securities discussed in LSA research reports may be unsuitable for some investors depending on their specific investment objectives, financial status, risk profile, or particular needs. Investors should consider LSA reports as only a single factor in making their investment decisions and should not rely solely on these reports in evaluating whether or not to buy or sell the securities of the subject company. LifeSci Advisors has been compensated by the company that is the subject of the report described and future research reports, investor relations services, and general consulting services. Please read each report's full disclosures and analyst background on the LSA website, www.lifesciadvisors.com, before investing. LifeSci Advisors is not a registered investment adviser or broker-dealer.

Forward-looking statements:

This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. These forward-looking statements represent LSA's judgment as of the date of this release. LifeSci Advisors disclaims, however, any intent or obligation to update these forward-looking statements.

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