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N.C. diagnostics firm LipoScience files for $86M IPO

N.C. diagnostics firm LipoScience files for $86M IPO

Diagnostics company LipoScience aims to become North Carolina’s next public company.

Raleigh, North Carolina-based LipoScience has filed with securities regulators plans to raise up to $86.2 million in an initial public stock offering. It’s the second time LipoScience has flirted with a public stock offering. The company filed IPO plans in 2001, only to withdraw them in 2002 due to market conditions. But recent market conditions have improved; LipoScience’s IPO would follow the Durham company Tranzyme Pharma‘s (NASDAQ:TZYM) $48 million public offering in April.

LipoScience plans to use proceeds from its stock offering to expand its sales and marketing and fund continued R&D for new tests to supplement an already commercialized blood test to gauge the risk of cardiovascular disease. LipoScience is targeting the cholesterol testing market, which represents an estimated 75 million tests each year in the United States.

Last year, LipoScience recorded more than 6 million orders for its lipoprotein test and the company reports that from 2006 to 2010, test orders have increased at a compound annual growth rate of approximately 30 percent. That growth has been helped by insurance industry acceptance of the test. The NMR LipoProfile test is covered by a number of payors including Medicare, TRICARE, WellPoint, United HealthCare and several Blue Cross Blue Shield affiliates.

“We plan to significantly increase our geographic presence across the United States to expand market awareness and penetration of the NMR LipoProfile test, with the goal of ultimately becoming a clinical standard of care,” the company said in the filing.

LipoScience’s proprietary blood test counts the number of lipoprotein particles in a blood sample in order to gauge cardiovascular risks. LipoScience’s patented technology uses nuclear magnetic resonance to test for lipoproteins, which the company says are a better measure of cardiovascular risk than cholesterol levels.

The testing technology was developed at North Carolina State University by biochemistry professor James Otvos, who is now the company’s chief scientific officer.Otvos founded LipoScience in 1994 and by 1999, the company had developed tests to sell to clinicians and diagnostic laboratories. Investors in the company include Durham, North Carolina-based Pappas Ventures and Three Arch Partners, a Bay Area venture firm.

When LipoScience pulled its IPO plans nine years ago, the company’s revenue was $18.5 million. According to LipoScience’s most recent filing, the company generated $39.3 million in 2010 revenue. The company turned a profit of $4.3 million last year. But the filing notes that although LipoScience recorded profits in 2009 and 2010, it incurred a $500,000 loss in the first quarter of 2011. The company does not expect to be profitable this year or in coming years as it expands its growth strategy for its NMR LipoProfile test and develops new diagnostics. The company is also developing tests for diabetes and other diseases.

LipoScience expects that its latest diagnostic device should raise the market potential for its blood tests even more. Right now, blood samples using LipoScience’s tests must be sent to the company’s Raleigh headquarters to complete the testing because it’s the only facility with the proper equipment. But the company has developed a machine, called Vantera, that will allow institutions or laboratory testing facilities to complete that testing at their own sites. Vantera has already been site tested at a number of facilities across the country, including the Mayo Clinic and the Cleveland Clinic. LipoScience plans to file with the U.S. Food and Drug Administration for 510(k) clearance on Vantera by the end of this year.

LipoScience - 06/24/2011

Achillion Initiates 12-Week Dosing in Phase 2 Trial of ACH-1625 for the Treatment of Chronic Hepatitis C

NEW HAVEN, Conn., June 22, 2011 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced that the Company has initiated patient dosing in segment 2 of its Phase 2 clinical trial of ACH-1625 for the treatment of hepatitis C virus (HCV) for genotype 1 treatment naïve HCV-infected patients. ACH-1625, discovered and advanced by Achillion, is a potent small molecule inhibitor of HCV protease, an enzyme necessary for viral replication.

Achillion Pharmaceuticals - 06/22/2011

Achillion Initiates 12-Week Dosing in Phase 2 Trial of ACH-1625 for the Treatment of Chronic Hepatitis C

NEW HAVEN, Conn., June 22, 2011 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced that the Company has initiated patient dosing in segment 2 of its Phase 2 clinical trial of ACH-1625 for the treatment of hepatitis C virus (HCV) for genotype 1 treatment naïve HCV-infected patients. ACH-1625, discovered and advanced by Achillion, is a potent small molecule inhibitor of HCV protease, an enzyme necessary for viral replication.

The clinical trial has advanced into the second segment of a Phase 2a, randomized, double-blind trial evaluating the safety, tolerability and antiviral activity of oral ACH-1625 in combination with standard of care (SOC) consisting of pegylated interferon alfa-2a and ribavirin. Patients will be randomized to receive once daily doses of 200 mg, 400 mg or 800 mg of ACH-1625 in combination with SOC for 12 weeks of dosing. Patients will continue to receive an additional 12 weeks of pegylated interferon alfa-2a and ribavirin and eligible to discontinue treatment at week 24 if they achieve extended rapid virologic response (eRVR) at week 12. Patients who do not achieve an eRVR will continue to receive SOC until week 48.

The trial will take place in the United States and Europe and is designed to enroll approximately 60 HCV-infected patients. The 12-week complete early virologic response (cEVR) trial results are anticipated to be announced in the fourth quarter of 2011.

"Initiating the second segment of this Phase 2 clinical trial allows us to build upon the robust RVR results we observed with ACH-1625, and to further augment the safety and efficacy database by taking the opportunity to study multiple doses of ACH-1625," commented Elizabeth A. Olek, D.O., Vice President and Chief Medical Officer of Achillion. "We expect that the results will provide important insight to benchmark the activity of our once-daily protease inhibitor and we look forward to reporting cEVR results by the end of this year."

"This next study segment with ACH-1625 is yet another important milestone achieved for this potentially best-in-class protease inhibitor and for Achillion's broader HCV pipeline," said Michael D. Kishbauch, President and Chief Executive Officer of Achillion.

Achillion Pharmaceuticals - 06/22/2011

Tesaro Garners $101,000,000 Series B Financing Round

TESARO is a privately held oncology-focused biopharmaceutical company whose passionate associates are dedicated to improving the lives of cancer patients by developing and providing safer and more effective therapeutics and supportive care products.

TESARO plans to develop one or more compounds for oncology indications, including the treatment of patients with non-small cell lung cancer (NSCLC) whose tumors express an ALK fusion protein; recent clinical proof-of-concept has been demonstrated for ALK inhibition in this patient population. The Series B financing will fund further development of these programs and expansion of the pipeline.

TESARO - 06/21/2011

Ultragenyx Announces Series A Financing

 
$45 million to support development of rare disease therapeutics

NOVATO, Calif., June 20, 2011--(EON: Enhanced Online News)--Ultragenyx Pharmaceutical Inc. today announced the closing of a $45 million Series A financing to support the development of rare disease therapeutics. The co-lead investors are TPG Biotech and Fidelity Biosciences, joined by European investor HealthCap, and Pappas Ventures. This funding will advance multiple rare disease product programs in the pipeline, as well as the development of new product candidates and partnerships. The lead product, UX-001, a first-in-class therapy for treatment of Hereditary Inclusion Body Myopathy (HIBM), is expected to enter the clinic in 2011.

Ultragenyx Pharmaceutical - 06/20/2011

Ultragenyx Announces Series A Financing

$45 million to support development of rare disease therapeutics

June 20, 2011 10:03 AM Eastern Daylight Time 

NOVATO, Calif.--(EON: Enhanced Online News)--Ultragenyx Pharmaceutical Inc. today announced the closing of a $45 million Series A financing to support the development of rare disease therapeutics. The co-lead investors are TPG Biotech and Fidelity Biosciences, joined by European investor HealthCap, and Pappas Ventures. This funding will advance multiple rare disease product programs in the pipeline, as well as the development of new product candidates and partnerships. The lead product, UX-001, a first-in-class therapy for treatment of Hereditary Inclusion Body Myopathy (HIBM), is expected to enter the clinic in 2011.

"I am pleased and excited to have found a set of investors with the insight to support the development of a new rare disease company with multiple product candidates. They believe in the concept that a tightly focused company of committed rare disease development specialists will be able to create value as well as bring a series of novel, life-changing therapeutics to patients affected by rare and ultra-rare disorders," said Emil D. Kakkis, M.D., Ph.D., Chief Executive Officer and President of Ultragenyx.

Dr. Kakkis formed and funded Ultragenyx in April 2010, based on his experiences in academia and over 11 years at BioMarin, where three rare disease products were approved during his tenure. The company has received additional funding from John Klock, M.D., and William Aliski, both experienced rare disease company executives. Joining the Ultragenyx Board of Directors are Eran Nadav, Ph.D. (TPG Biotech), Ben Auspitz (Fidelity Biosciences) and Mårten Steen, M.D., Ph.D. (HealthCap).

The company will be located in Novato, CA.

About Ultragenyx

UltragenyxTM develops therapeutics for rare diseases, sometimes referred to as Orphan products. Founded in 2010, the company is led by Emil Kakkis, M.D., Ph.D., former CMO of BioMarin Pharmaceutical. Efficient and effective development strategies are essential for success in the rare disease space, in which information may be incomplete or ambiguous, and few development precedents exist. The management team's experience in selecting and developing products with clear mechanisms of action for untreated rare diseases will help Ultragenyx create life-changing therapeutics by leveraging existing yet undeveloped science for these little-known indications.

Ultragenyx Pharmaceutical - 06/20/2011

Pappas Ventures-Backed Lumena Pharma Bumps up Debt Offering to $2M - cbl

DURHAM -- Lumena Pharmaceuticals Inc. has secured $500,000 of its bumped-up debt offering to $2 million.

The Durham-based company, founded earlier this year, disclosed the higher amount in an SEC amended filing, after reporting in February the sale of debt worth $250,000 to two investors.

Principals named in the current filing are executive director Michael Grey, executive officer Ford Worthy and director Rosina Maar Pavia, all of Pappas Ventures, plus Frankfort, Mich.-based Ted Greene, chairman of Satiogen Pharmaceuticals Inc. and a scientist who holds several patents.

Founded in 1994, Pappas Ventures has more than $350 million in capital under management. The Durham-based firm has invested in more than 50 life sciences companies, including Cerexa (acquired by Forest Laboratories), Peninsula Pharmaceuticals (acquired by Johnson & Johnson), Syntonix (acquired by Biogen IDEC), NuVasive and Arena Pharmaceuticals.

Grey is a pharmaceutical industry veteran who previously led SGX Pharmaceuticals Inc. and Auspex Pharmaceuticals. He is a member of Pappas Ventures' scientific advisory board and a venture partner.

Lumena Pharmaceuticals - 06/17/2011

One-Year Follow-Up Results From Athersys' Phase I Study of MultiStem in Heart Attack Patients Presented at International Stem Cell Symposium

Data Suggest MultiStem Provides Longer-Term Benefit in Heart Function in Heart Attack Patients Athersys, Inc. announced positive results from the analysis of one-year follow-up data from its Phase I clinical trial of MultiStem(R), its allogeneic adult stem cell product, administered to individuals following acute myocardial infarction (AMI), more commonly referred to as a heart attack. Dr. Marc Penn, M.D., Ph.D., co-principal investigator of this study and Director of Cardiovascular Cell Therapy at the Cleveland Clinic, and Director of the Skirball Laboratory for Cardiovascular Cellular Therapeutics, presented the results on June 10, 2011 at the Eighth International Symposium on Stem Cell Therapy and Cardiovascular Innovations in Madrid, Spain. The long-term follow-up, based on one year of patient data, suggests that trends observed at four months -- indicating a benefit in heart function from MultiStem treatment -- were continued through twelve months.

Dr. Penn presented new information from the one-year follow-up data collected from patients in the Phase I study, showing benefit in heart function through twelve months in patients treated with MultiStem.

Athersys - 06/13/2011
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