Category: Bioscience

Broomfield-based startup applies to FDA for first product

BROOMFIELD — Medical-device startup Colorado Therapeutics LLC in Broomfield has filed an application with the Food and Drug Administration for its first product.

The product, a sheathlike membrane, will reinforce and regenerate soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft-tissue membranes, including the repair of hernia defects.

The membrane combines biologic and synthetic products and will be packaged in a dry state requiring no preparation or rehydration.

Colorado Therapeutics is working on other uses, including dental applications used for periodontal and oral surgery, vein grafting, and tendon/ligament repair or replacement.

The company raised an angel round of funding to cover the cost of preparing the application, and it is planning to launch a Series A funding round.

The company was launched in April 2015 by Broomfield-based Colibri Heart Valve, a medical-device company that is developing products for structural heart repairs, to use Colibri’s technology to develop and market products that can be used to repair soft tissue outside the heart.

Joseph B. Horn, Colibri’s president and chief executive, said the formation of Colorado Therapeutics is allowing Colibri to monetize the company’s proprietary technology in applications outside of the heart and focus on the development of structural heart products such as the Colibri TAVI System, which is preparing to enter a CE Mark clinical program.

The system delivers a heart valve that can be implanted without requiring full open heart surgery. The valve that is implanted via a needle-puncture rather than an opening created by a scalpel.

The TAVI System has been successfully tested in a first-in-human study in patients with severe aortic valve stenosis who are deemed very high risk for open-heart valve-replacement surgery.

To support the CE Mark clinical program, Colibri will convert all outstanding senior secured notes and open a Series C financing round.

Clovis posts net loss, plans new-drug application

BOULDER — Officials for Boulder pharmaceutical company Clovis Oncology on Thursday reported a 2015 net loss of $352.9 million, and also said the company is planning to submit a new-drug application for cancer drug rucaparib to the U.S. Food and Drug Administration sometime during the second quarter of this year.

Clovis’ loss amounted to $9.79 per share as the company works toward gaining FDA approval for a pair of its cancer drugs this year.

The FDA is expected to make a decision on lung cancer drug rociletinib by the end of June. In addition to the upcoming NDA for the use of rucaparib in the treatment of ovarian cancer, the company also is planning to initiate a study of that drug in the second half of this year looking at its use in the treatment of prostate cancer.

If approved, rociletinib would be the first drug to market for Clovis.

“2016 has the potential to be a very transformational year for Clovis,” chief executive Patrick Mahaffy said in the company’s earnings report. “Our U.S. commercial and medical affairs organizations are in place as we work toward the potential launch of two oncology drugs in the U.S. within the next 12 months.”

Clovis, which had no revenue for 2015, reported a fourth-quarter net loss of $119.5 million, or $3.12 per share. The company finished the year with $528.6 million in cash, cash equivalents and available-for-sale securities. Research and development expenses for the fourth quarter totaled $76 million, and $269.3 million for the year. That’s compared with $50.1 million and $137.7 million, respectively, for the fourth quarter and full year 2014.

Thursday’s earnings report came after markets closed.

Despite the company’s optimism surrounding the New Drug Applications, Clovis has seen its share price languish since November when the firm announced the FDA had requested more clinical data on rociletinib. That request caused the goal date for a decision on the drug to be pushed back from March to June, and caused Clovis’ stock price to plunge from a closing price of $99.43 on Nov. 13 to a close of $30.24 the following Monday.

Clovis shares sank 79 cents on Thursday to close at $17.29, not far off their 52-week low.

GlobeImmune’s CEO cuts own hours, salary to preserve capital

LOUISVILLE — GlobeImmune Inc.’s chief executive Timothy C. Rodell will work part-time beginning March 1 to help preserve capital for the struggling biopharma based in Louisville.

Rodell, whose full-time annual salary was $405,000, will cut his hours in half and will earn a salary of $202,500, according to documents filed Tuesday with the Securities and Exchange Commission.

In August, GlobeImmune. (Nasdaq: GBIM) reduced its workforce from 22 to six employees, according to documents filed with the SEC, in an effort to preserve cash after negative trial results of its hepatitis B drug candidate. The company is focused on developing products for the treatment of cancer and infectious diseases. Also in August, GlobeImmune hired Cantor Fitzgerald & Co. to assist in evaluating strategic alternatives to maximize value for GlobeImmune’s stockholders.

GlobeImmune raised $17.25 million through an initial public offering in July 2014, selling shares for $10 each. Its stock was trading at $1.17 per share mid-day Wednesday.

In its most recent earnings report for the third quarter of 2015 that ended Sept. 30, GlobeImmune reported net income of $900,000, compared with a loss of $6.4 million for the same period in 2014.

During the quarter, Celgene Corp. exercised its option to exclusively license GlobeImmune’s GI-6207 program for medullary thyroid cancer.

On Feb. 18, Jeffrey Bartelt of Wauwatosa, Wis., purchased 302,200 shares, or 5.2 percent of the company, according to SEC documents.

FDA grants Nivalis cystic fibrosis drug Fast Track status

BOULDER — Nivalis Therapeutics Inc. (Nasdaq: NVLS) got another boost from the U.S. Food and Drug Administration this week as the company’s cystic fibrosis drug N91115 was granted Fast Track designation.

The FDA designation provides for accelerated review of drugs intended to treat serious or life-threatening conditions and address unmet medical needs.

The Fast Track designation comes just a month after Nivalis landed Orphan Drug designation for N91115. That designation provides special status to drugs intended to treat, diagnose or prevent diseases that affect fewer than 200,000 people in the United States.

N91115 is currently in the middle of a Phase 2 clinical trial, with results expected later this year.

Huvepharma completes acquisition of Zoetis operations in Longmont

LONGMONT — Bulgarian pharmaceutical company Huvepharma closed this month on the acquisition of a Zoetis facility in Longmont that makes animal-health products for livestock, including poultry, swine and cattle.

The deal became official Friday, with Huvepharma — which has its U.S. headquarters in Peachtree City, Ga. — taking over operations of the Longmont facility and ownership of the products made there. Huvepharma Inc. chief financial officer Darius Gazinschi said all 16 Zoetis employees in Longmont became Huvepharma employees.

The sale was part of a larger deal that saw Huvepharma also buy a Zoetis manufacturing facility in North Carolina and assume the assets, operations and lease of a Zoetis manufacturing and distribution site in Arkansas. New Jersey-based Zoetis (NYSE: ZTS) disclosed in a recent filing with the U.S. Securities and Exchange Commission that the company would receive $40 million in “cash and additional considerations” in the deal.

Included in that price was the $3.5 million real estate purchase of Zoetis’ Longmont facility at 1301 Iowa Ave., which according to Boulder County property records is a roughly 65,000-square-foot building constructed in 1973.

Huvepharma is a 15-year-old company that develops, makes and sells both human and animal-health products. The privately held company doesn’t disclose revenue. It has five manufacturing facilities in the United States in addition to the Georgia location.

Gazinschi characterized the Longmont purchase as a growth acquisition that adds to Huvepharma’s portfolio of products rather than overlaps. While he didn’t indicate that the company would be adding staff at the Longmont facility in the immediate future, he said Huvepharma has been growing in general in the United States. He said no changes are planned for the Longmont site.

“We need to have this facility continue to produce for us,” Gazinschi said. “Those are our immediate plans.”

For Zoetis, the sale was part of an ongoing “operational efficiency” plan launched by the company last year to simplify and streamline the company. As part of that plan, the company is divesting certain assets and closing other facilities. The recent SEC filing noted that the company is divesting lower-revenue, lower-margin products to help improve profitability.

Zoetis formed in 2013 out of a spinoff of Pfizer’s Animal Health division. The Longmont facility had been an Alpharma site before Pfizer acquired Alpharma in 2011.

Biodesix lands $17.8M Series F funding round

BOULDER — Diagnostic test-maker Biodesix Inc., has raised a Series F funding round worth nearly $17.8 million, according to a recent filing with the U.S. Securities and Exchange Commission.

Biodesix CEO David Brunel couldn’t be reached for comment Tuesday.

The round includes the conversion of convertible promissory notes. The company disclosed in October that it had raised $8.6 million in convertible debt. Brunel said then that company officials were “watching the markets” and monitoring the company’s own progress before settling on a price for the new equity funding round.

Biodesix makes a line of blood tests aimed at identifying which cancer patients could best benefit from various cancer drugs, because most cancer drugs work only on specific sets of the population. In essence, the tests help get the right drugs to the right patients.

At the time of the debt raise in October, Brunel said that new cash would go toward continued support of sales and marketing of its Veristrat product, as well as development of new tests for immunotherapy.

Veristrat has about 120 employees, about half of which are in Boulder.

EndoShape reports raising $1.8M in new funds

BOULDER — Medical-device company EndoShape Inc., has raised about $1.8 million in new funding, according to a recent filing made with the U.S. Securities and Exchange Commission.

A company official on Wednesday said he couldn’t comment on the funding at this time.

According to the filing, the new funds add to a funding round first disclosed last year that had reached about $1.2 million at that point.

EndoShape’s Medusa MultiCoil is a device used for the embolization, or blocking, of blood vessels. It’s used to close off vessels that might be ruptured and causing internal bleeding or vessels that are feeding a tumor.

EndoShape received U.S. Food and Drug Administration approval for the device in 2013. That clearance was followed by a $5.9 million funding round in 2014.

Array’s loss widens as biopharma preps for commercialization

BOULDER — Array BioPharma Inc. (Nasdaq: ARRY) on Tuesday reported a loss of $24.2 million, or 17 cents per share, on revenue of $35.4 million for its fiscal second quarter that ended Dec. 31.

Compared with the same quarter of fiscal 2015, the Boulder-based drug development company’s revenue increased $8.5 million, primarily due to $27.3 million in reimbursement revenue from Novartis.  Net loss was roughly triple compared with the $8.6 million, or 6 cents per share, reported for the same quarter in fiscal 2015.

Ron Squarer, Array’s chief executive, said the company continues to make progress with its melanoma-fighting drugs binimetinib and encorafenib in clinical trials and expects to submit them to regulatory authorities for marketing approval this year.

In November, Array and Pierre Fabre announced a collaboration agreement for binimetinib and encorafenib. Under the terms of the agreement, Array received an upfront payment of $30 million in January and retains exclusive commercialization rights for binimetinib and encorafenib in key territories, including the United States and Japan.  Pierre Fabre will have exclusive rights to commercialize both products in other territories, including Europe, Asia and Latin America. Array is entitled to receive up to $425 million if certain development and commercialization milestones are achieved, and is eligible for double-digit royalties.

For the six months ended Dec. 31, revenue was $51.6 million, compared with $33 million for the same period in fiscal 2015. Net loss for the six months ended Dec, 31 was $45.2 million, or 32 cents per share per share, compared with a net loss of $36.2 million, or 27 cents per share, in the comparable prior-year period.

Array’s stock was trading at $3.11 per share mid-day Tuesday. Its 52-week range is $2.78 to $8.59 per share.

Encision trims loss but revenue declines

BOULDER — Medical-device manufacturer Encision Inc. (PK: ECIA) on Tuesday reported revenue of $2.3 million and a loss of $200,000, or 2 cents per share, for its fiscal 2016 third quarter that ended Dec. 31.

The Boulder-based company makes tools for surgeons that prevent stray electrosurgical burns in minimally invasive surgery.

The results compare with revenue of $2.6 million for a net loss of $417,000, or 4 cents per share, for the same quarter a year ago.

For nine months, the company posted revenue of $7 million and a loss of $598,000, or 6 cents per share, compared with revenue of $7.4 million and a loss of 1 million or 10 cents per share, for the same period a year ago.

In the coming quarter, Encision is expected to release it latest innovation — the AEM EndoShied 2 Burn Protection System. The company said the reposable monitor will reduce the cost per procedure to a hospital and will interface with its existing electrosurgical generators.

Encision’s stock is trading at 60 cents per share. Its 52-week range is 27 cents to 90 cents per share.

Clovis Oncology initiates combo clinical trial with rociletinib, Genentech drug

BOULDER – Clovis Oncology Inc. (Nasdaq: CLVS) on Wednesday announced that it has begun a clinical trial looking at the use of drug candidate rociletinib in combination with Genentech’s drug atezolizumab to treat lung cancer.

Clovis is sponsoring the Phase 1b/2 trial, though specific terms of the deal were not announced. The first portion of the trial will be used to assess the safety and activity of the drug combination, while the second portion will evaluate activity of the drug in two subgroups of patients with EGFR-mutant advanced or metastatic non-small cell lung cancer.

The first patient is expected to be enrolled in the coming weeks at the University of California Los Angeles, though patients will be enrolled in the study throughout the United States and Europe, company officials said.

Clovis is aiming for 2016 to be a big year for rociletinib, which is in a series of trials looking at its use in the treatment of non-small cell lung cancer. The path to regulatory approval, however, hasn’t come without some bumps, including delays, a sagging stock price and lawsuits from shareholders.

Clovis last summer filed a New Drug Application with the U.S. Food and Drug Administration for rociletinib’s use in treating lung cancer, with a decision originally slated for March 30. But the company announced in November that the FDA had requested more data on rociletinib in part because the number of study patients with unconfirmed responses to the drug who had converted to confirmed responses was lower than had been expected.

That caused the FDA to extend the goal date for a decision on the drug to June 28, and led to a major selloff of Clovis stock that saw the company’s share price crash from nearly $100 to less than $26 in just more than a week’s time.

Clovis shares were trading at $21.22 just before Wednesday’s closing bell, down more than 5 percent from Tuesday’s close.