Dr. Paul Lem, CEO

Closely-held Spartan Bioscience’s recently launched an on-site rapid DNA test for Legionnaires’ disease that has the potential to eliminate lengthy culture testing in third-party labs and detect the Legionella bacteria ahead of an outbreak of the disease.

“On-site Legionella DNA testing is the first practical way to monitor and prevent Legionella outbreaks in many office buildings, hotels, schools and shopping centers,” Dr. Paul Lem, CEO, says in an interview with BioTuesdays. “With widespread testing, there is the potential to basically eradicate Legionnaires’ disease.” 

The Legionella test utilizes Spartan’s coffee-cup-sized, portable DNA analyzer, the Spartan Cube, and single-use disposable test cartridges that can detect and quantify Legionella bacteria in 45 minutes, compared with up to two weeks with conventional cultures. The Cube is the world’s smallest commercial molecular diagnostic device.

The Cube is the world’s smallest commercial molecular diagnostic device

Dr. Lem explains that the technology is based on a highly accurate Nobel Prize winning chemistry called quantitative polymerase chain reaction (qPCR) and is designed to meet ISO technical standards. The system won the 2018 AHR Expo Innovation Award for Indoor Air Quality, as judged by the American Society of Heating, Refrigerating and Air-Conditioning Engineers.

Spartan’s product portfolio also includes a test for the CYP2C19 gene mutation, which can impair drug metabolism, and an Alzheimer’s disease risk test cartridge, which is being used by several pharmaceutical companies in clinical trials.

“Our business focus covers medical and non-medical testing, with a pipeline in three categories: pharmacogenetics, infectious diseases and environmental risks,” Dr. Lem points out.

Legionella is a naturally occurring bacterium found in ponds and streams but does not exist in high concentrations in its natural habitat. However, it can become wind borne, infecting cooling towers of heating, ventilation and air conditioning systems of large office buildings and hotels, and providing an ideal environment for the bacteria to grow. 

“Infected cooling towers release aerosolized water droplets contaminated with Legionella into the surrounding air,” Dr. Lem says, adding that building occupants who breathe in these water droplets can develop Legionnaires’ disease, a potentially fatal pneumonia. 

There are some three million to five million cases of pneumonia in the U.S. each year, with 2% to 9% diagnosed as Legionnaires

There are some three million to five million cases of pneumonia in the U.S. each year, with 2% to 9% diagnosed as Legionnaires. According to the WHO, the mortality rate for Legionnaires is 5% to 10% for non-hospitalized cases and 15% to 20% for hospitalized cases. The CDC also estimates the disease costs the healthcare system $101-million to $321-million a year.

“In the medical system, we do not routinely test for Legionnaires, so the disease is under diagnosed,” Dr. Lem suggests. New York City made testing for Legionnaires mandatory last year.

Legionella acquired its name after an outbreak of a then unknown mystery disease sickened 221 people, resulting in 34 deaths, at a convention of the American Legion in Philadelphia in July 1976. The causative agent was identified as a previously unknown bacterium six months later and named, Legionella.

Currently, Legionella bacterial culture testing of water samples from cooling towers can take up to two weeks, which Dr. Lem contends is too slow because Legionella can reach outbreak levels in as few as seven days.

A CDC study several years ago found that Legionella culture can underestimate actual Legionella levels by a factor of 10 or more. And culture incorrectly reported that water samples were negative for Legionella an average of 11.5% of the time when in fact they were positive.

According to Dr. Lem, buildings with cooling towers should test for Legionnaires weekly. Using the Spartan Cube and disposable test cartridges would cost $5,000-to-$10,000 a year. There are an estimated 150,000 office buildings with cooling towers in the U.S. and 500,000 worldwide, representing a market potential of more than $1-billion. “And that excludes schools, hotels and shopping centers,” he adds.

Spartan has dedicated a 10-person sales team to promote the Legionnaires test to property owners and managers across North America, with Dr. Lem suggesting the size of the team would likely grow because of the “substantial demand we’re seeing. We want to bring the test worldwide because the Europeans also are very interested in Legionnaires testing.”

The Canadian government, through its Public Services and Procurement Canada arm, is currently conducting a study of Spartan’s Legionnaires system against culture testing, as a first step to potentially adopting the test in government buildings across the country.

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Morgan Brown, EVP and CFO

Although Lipocine (NASDAQ:LPCN) is disappointed by a FDA advisory committee vote against the benefit/risk profile of TLANDO, its oral testosterone replacement therapy (TRT), the company believes there is still a path forward for TLANDO.

“Efficacy and safety results from numerous clinical studies with TLANDO are consistent with other FDA approved TRT products,” Morgan Brown, EVP and CFO of Lipocine, says in an interview with BioTuesdays. 

“We are currently assessing appropriate clinical and regulatory next steps,” he adds. “We continue to believe that we have the right dose for a TRT therapy, which has comparable blood pressure data to AndroGel 1.62%,” an approved topical TRT, which comes with a Black Box warning, however, about secondary transfer to women and children.

Earlier this month, the Bone, Reproductive and Urologic Drugs Advisory Committee of the FDA voted six in favor and thirteen against the benefit/risk profile of TLANDO, an oral pill indicated for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males.

The FDA decision on whether or not to approve the TLANDO NDA is anticipated by the assigned PDUFA date of May 8, 2018. The NDA includes efficacy and safety data on TLANDO, including results from three Phase 3 clinical trials.

Notwithstanding the TLANDO setback, Mr. Brown contends that Lipocine has a very robust product candidate pipeline outside of its lead asset.

Late-Stage Pipeline

“Our next generation oral TRT product candidate, LPCN 1111, has the potential for once-daily dosing and we currently have a meeting scheduled with the FDA in February to discuss a Phase 3 clinical protocol,” he points out. 

In addition, Lipocine has potentially the first oral product candidate, LPCN 1107, for the prevention of preterm birth. LPCN 1107 has received orphan drug designation from the FDA. 

Mr. Brown says broad stroke agreement has been reached with the FDA on the Phase 3 protocol for LPCN 1107 and a final agreement will occur once a food/fat effect study is complete.

While Lipocine has demonstrated that TLANDO can reliably increase testosterone levels for 10-to-12 hours on a single dose, the company’s next generation oral TRT, LPCN 1111, can reliably increase testosterone levels for 22-to-24 hours on a single dose.  Both product candidates use Lipocine’s Lip’ral technology to enhance solubility and improve systemic absorption.

Mr. Brown explains that LPCN 1111 has demonstrated feasibility of once-daily dosing in Phase 2a and 2b clinical trials. “Our single-daily oral dose provides testosterone levels in the eugonadal range, with obvious market share benefits,” he adds.

Primary objectives were met in the Phase 2b study, including identifying the dose to be tested in a Phase 3 study. Good dose-response relationship was observed over the tested dose range in the Phase 2b study and the target Phase 3 dose met primary and secondary end points. LPCN 1111 also was well tolerated with no drug-related severe or serious adverse events.

Hypogonadism affects up to 20 million men in the U.S., of which six million have been diagnosed. While 2.2 million currently are being treated, some 3.8 million have been diagnosed but are untreated.

Hypogonadism affects up to 20 million men in the U.S.

Mr. Brown points out that market research suggests there is high interest for an oral TRT product, with 85% of interviewed physicians having a strong interest in an oral alternative to treat hypogonadism and 94% of interviewed patients likely to ask their physician about an oral TRT alternative.

In its women’s health division, Mr. Brown says LPCN 1107 has the potential to be the first oral product for the prevention of recurrent preterm birth, which is any delivery before 37 weeks of gestation and represents an unmet medical need.

The current standard of care is AMAG’s Makena, which requires 20-to-22 weekly intramuscular injections to prevent recurrent preterm birth. Makena is administered through a 21-guage needle, with each treatment of the viscous oily product taking up to one minute. During clinical testing of Makena, some 35% of women experienced injection site pain and 17% reported injection site swelling, exceeding placebo.

According to the CDC, 12% of all annual U.S. pregnancies result in preterm birth, a leading cause of neonatal mortality and morbidity. Published studies also indicate that 28% of preterm births are to women with a history of early delivery and first year medical costs for preterm birth infants can be 10 times higher than full term infants.

Mr. Brown explains that LPCN 1107 contains the same active ingredient - hydroxyprogesterone caproate - as Makena and “we believe that an oral alternative has the potential to be a major contributor to patient care.”

Lipocine has completed an end-of-Phase 2 meeting with the FDA and submitted its Phase 3 protocol for LPCN 1107 via a special protocol assessment. Manufacturing scale up work has recently been completed in preparation for a pivotal trial.

Mr. Brown says the Phase 3 trial would be a non-inferiority study of LPCN 1107 against intramuscular injections of Makena, with a one-to-one randomization, and primary efficacy analysis using a pre-specified non-inferiority margin of 7%.

The Phase 3 protocol also includes an adaptive design, with an interim analysis, that will allow Lipocine to review the results after roughly one-third of the subjects have completed the study and determine if the results are consistent with pre-determined endpoints.   

“If an interim analysis indicates that we are on track to demonstrate non-inferiority based on superiority assumptions, we may be able to enroll fewer subjects in the study before seeking regulatory approval,” he adds.

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Charlie Deignan, CFO

Clearside Biomedical (NASDAQ:CLSD) is expected to report several key milestones in 2018 in its programs of developing potential treatments for back of the eye diseases with its corticosteroid therapy, CLS-TA, administered through the suprachoroidal space (SCS) to readily access the retina and choroid and thereby target disease pathology. 

CLS-TA is Clearside’s suspension formulation of the corticosteroid, triamcinolone acetonide, for suprachoroidal administration.

“There are several key milestones in 2018 that are important inflection points for our potential treatments of eye diseases with our SCS platform,” Charlie Deignan, CFO, says in an interview with BioTuesdays. 

Focused Pipeline of SCS Treatments for Multiple Blinding Eye Diseases

Clearside’s upcoming milestones include top line data from a pivotal Phase 3 trial in non-infectious uveitis in the first quarter and top line data from a Phase 2 study in diabetic macular edema (DME) in the second quarter. 

And in the first quarter of 2019, the company expects to release top line results from a first Phase 3 trial in patients with retinal vein occlusion (RVO). 

Mr. Deignan explains that precise access to the back of the eye through the SCS for CLS-TA has the benefit of potentially resulting in high drug concentrations at the sites of disease in the retina and choroid, and away from the anterior chamber and lens where side effects occur, such as cataracts and the elevation of intraocular pressure. 

Precise Access to the Back of the Eye Through the SCS

“Our extensive patent estate includes proprietary access to the suprachoroidal space and for treatments of eye diseases through this 17-square cm area of the eye,” he adds.

In addition to RVO, uveitis and DME, Clearside also is collaborating with multiple companies in preclinical programs, evaluating potential pharamacologic candidates for treatments of diseases through the SCS. These studies include approaches to treat retinal vascular diseases and gene therapy.

“The objectives of our clinical programs are improved benefit-to-risk ratios, rapid vision gains, consistent patient response and sustained vision improvement,” Mr. Deignan points out.
 
A good example is in Clearside’s program in RVO, the second most common cause of blindness from retinal vascular disease after diabetic retinopathy. RVO is a blockage of the veins that carry blood away from the retina, which converts light images to nerve signals and sends them to the brain. RVO affects 16 million people worldwide, with an estimated U.S. prevalence of 2.2 million people. 

Suprachoroidal CLS-TA with Intravitreal Eylea for Macular Edema Associated with RVO

According to Mr. Deignan, anti-VEGF agents are currently first-line therapy for macular edema secondary to RVO, and are used monthly initially before attempting to extend the interval between treatments. Phase 3 trials of anti-VEGF agents used six monthly injections.

Intravitreal corticosteroids are generally used as second-line treatment in patients with RVO when there is persistence of edema after a long course of injections of a VEGF-neutralizing protein, or when there appears to be an inability to substantially extend the period between anti-VEGF injections without recurrent edema. “There is a clear need here to improve this high treatment burden on RVO patients,” he suggests.

Clearside’s Phase 2 RVO trial, where outcomes from patients receiving a single suprachoroidal CLS-TA injection plus a single intravitreal Eylea injection were compared with outcomes from those receiving a single intravitreal Eylea injection only in treatment of naïve RVO patients, showed potential patient advantages in the combination arm. 

Patients in each arm could receive as needed intravitreal Eylea at each monthly visit. In the trial, patients in the combination arm showed greater improvement of vision starting at the first month, compared with those in the Eylea alone arm. 

In addition, the clinical benefit, both in terms of vision and retinal thickness, was sustained over the three-month trial period and there were significantly fewer additional Eylea treatments through the three-month trial.

“Faster improvement in vision is very important to doctors in the care of their patients because the earlier visual acuity gains in patients could not only result in earlier resolution of disease complications, but also could lead to better longer- term visual outcomes,” Mr. Deignan points out.

In addition, there were no serious adverse events in the combination arm in the Phase 2 study and no adverse events that led to patients discontinuing treatment.

In an extension study, Clearside found that 74% of patients who received combination therapy at baseline in the Phase 2 trial did not receive additional treatment through a minimum of a nine-month observation period.

Clearside’s first Phase 3 RVO trial is a yearlong study, and is currently enrolling 460 patients worldwide at 150 clinical sites, with 230 patients receiving the combination of CLS-TA plus Eylea, and 230 patients Eylea alone. Patients in the combination treatment arm will receive suprachoroidal CLS-TA together with intravitreal Eylea at the beginning of the trial, Eylea alone at week 4, and CLS-TA together with Eylea at weeks 12 and 24. 

Patients in the control arm will receive intravitreal Eylea alone at the beginning of the trial and follow-up treatments of Eylea alone every four weeks through week 24. 

After 24 weeks, patients will be followed for approximately an additional six months, with as needed treatments in each arm. The primary endpoint is superiority of best-corrected visual acuity after two months. 

Last August, Clearside completed enrollment of 160 patients in a pivotal Phase 3 trial of suprachoroidal CLS-TA for the treatment of macular edema associated with non-infectious uveitis. Patient follow-up in the trial is six months, leading to data readout in the current quarter. 

Enrollment in Suprachoroidal CLS-TA Phase 3 Trial Completed; Topline Data Expected in Q1 2018

“This is our most advanced clinical development program and the data readout will be our first key milestone in 2018,” Mr. Deignan says. 

The primary efficacy outcome measure in the Phase 3 trial is based on improvement in best-corrected visual acuity over the six-month duration of the study. Safety will be assessed by analyzing the occurrence of adverse events and changes in key safety parameters over the course of the trial. 

Based on feedback from an end-of-Phase 2 meeting with the FDA, Clearside believes that the current pivotal trial in non-infectious uveitis will be sufficient to support a potential new drug application filing at the end of 2018.

Uveitis is a set of inflammatory conditions affecting the eye and is one the world’s leading causes of blindness. Uveitis occurs in about 350,000 patients in the U.S. and is typically found in both eyes. Macular edema occurs in approximately one-third of all non-infectious uveitis cases and is a major contributor to vision loss in these patients. 

Administration of corticosteroids is the most common treatment for all forms of uveitis, including macular edema. “Corticosteroids show reasonable efficacy but 35% to 40% of patients develop elevated intraocular pressure, and similar numbers of patients have cataract formation or worsening,” Mr. Deignan notes.

In an earlier Phase 2 uveitis study, CLS-TA demonstrated substantial improvements in efficacy with a statistically significant reduction in retinal thickness and a statistically significant mean nine-letter eye chart improvement in best-corrected visual acuity. In addition, there were no corticosteroid-related increases in intraocular pressure, which was very important, Mr. Deignan adds.

A third Clearside program is in diabetic eye disease. DME is an accumulation of fluid in the macula caused by leaky blood vessels as a consequence of diabetes. DME is the most common complication of diabetes in patients with diabetic retinopathy. It may cause images to appear blurry or wavy and colors that seem washed out.

There are an estimated 29.1 million people with diabetes in the U.S., of which 1.1 million have DME. In Europe, there are some 55 million people with diabetes, of which 5.8 million have DME.
 
Current treatments for DME include anti-VEGF injections, with Eylea providing the greatest benefit in patients with poorer vision; corticosteroids, such as Iluvien and Ozurdex; and lasers to cauterize leaky blood vessels. Similar to the treatment of RVO, anti-VEGF agents appear to be first-line therapy in patients with DME.

A Phase 2 DME study has completed enrollment, with preliminary data expected in the second quarter this year. Patients will be evaluated on a monthly basis through the six-month trial period, with best-corrected visual acuity as the primary outcome measure.
 
“While the results of the exploratory Phase 2 remain to be seen, if suprachoroidal CLA-TA can provide a potential for the treatment of DME, this will represent an additional large market opportunity,” Mr. Deignan suggests.

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Christian Hogg, executive director and CEO

After 17 years of blistering growth in China, Hutchison China Meditech (Chi-Med) (AIM, NASDAQ:HCM) is taking center stage as a global drug innovator, with a fully integrated pipeline approaching regulatory approvals, a prolific discovery engine and an established commercial organization.

“We are endeavoring to become one of the first China-based biopharmaceutical companies to emerge on the global market, with therapies developed internally that can be competitive globally,” Christian Hogg, executive director and CEO, says in an interview with BioTuesdays.

Chi-Med’s innovation platform now comprises eight clinical drug candidates, primarily in oncology, in more than 30 clinical studies around the world and a scientific team of over 350 people based primarily in Shanghai. 

“We were established with a deep strength in chemistry and now poses a prolific discovery engine that includes four Phase 3 drug candidates, four proof-of-concept assets and a third wave of exciting targeted therapies that are expected to move into the clinic during the next five years,” he adds.

“We are endeavoring to become one of the first China-based biopharmaceutical companies to emerge on the global market, with therapies developed internally that can be competitive globally”

All eight of Chi-Med’s clinical drug candidates were designed internally with a focus on kinase selectivity, he points out, giving them the potential for high potency and less off-target toxicity, and an ability to be combined with other kinase inhibitors, as well as immunotherapy and chemotherapy agents.

Mr. Hogg joined the company in 2000 as its first employee and has been CEO since 2006. He has led all aspects of the creation, implementation and management of the company’s strategy, including the establishment of both the innovation and commercial platforms. Chi-Med is a member of CK Hutchison Holdings.

Chi-Med’s commercial platform was assembled over the past 17 years through the acquisition and integration of various pharmaceutical assets and joint ventures. It now manufactures and markets more than 200 drugs through a team of over 3,300 marketing personnel, covering more than 300 cities and towns in China. 

Chi-Med is guiding for 2017 revenue in a range of $225-million to $240-million, compared with $216-million for 2016, with consolidated commercial sales of almost $200-million for 2017 and sales of non-consolidated joint ventures approaching $500-million. The company also is forecasting a net loss of $13-million to $28-million for 2017 after R&D expenses of $85-million to $90-million. 
 
“This is an example of the balanced financial approach we have tried to employ for the past 17 years,” he adds.

In its innovation arm, Chi-Med has six Phase 3 trials underway or being completed as well as 18 Phase 1b/2 proof-of-concept trials with eight drug candidates, four of which are expected to reach pivotal testing by mid-2018. Some 3,100 patients and subjects have been treated in the company’s studies to date, with more than 300 dosed during the first half of 2017.

Mr. Hogg points to three important potential milestones for Chi-Med in early 2018.

They include a decision with partner, AstraZeneca, on a strategy for a Phase 3 registration trial of savolitinib and potential for submission for FDA breakthrough therapy designation in non-small cell lung cancer (NSCLC) in combination with AstraZeneca’s Tagrisso; potential NDA approval of fruquintinib in China and a launch in the first half of 2018 in advanced colorectal cancer; and a potential presentation of preliminary efficacy data from Phase 1/1b dose escalation/expansion studies of HMPL-523 in hematological cancer.

“Potentially, we could be one of the first Chinese companies to receive breakthrough therapy designation from the FDA and consequently, possibly the first Chinese company to take a discovery all the way through to U.S. approval, which we are hoping to do with savolitinib,” Mr. Hogg suggests. “We are also looking forward to our first approval in China with fruquintinib, which we hope will lead to approvals in further indications during the next few years.” 

Mr. Hogg explains that savolitinib has been designed to be the first selective inhibitor of the c-MET receptor to eliminate the renal toxicity exhibited by first generation selective c-MET inhibitors. Over activity of the c-MET receptor has been linked with certain types of cancer cell division and must be turned off to improve patient outcomes in these patients.

“Clinical efficacy has been observed in NSCLC, kidney, gastric and colorectal cancers,” he contends, adding that some 500 patients have been treated with savolitinib to date, with no material renal toxicity having been observed.

However, the biggest opportunity for savolitinib is in NSCLC, Mr. Hogg points out, not only in the treatment of first-line naïve patients, but also those patients that have become resistant to first-line treatment with Iressa/Tarceva, and those that have become resistant to second-line treatment with Tagrisso. 

“The further you go along the current treatment paradigm, the more c-MET emerges as a resistance pathway to existing therapies,” he suggests. For example, he points out that of patients who fail on Tagrisso, c-MET aberrance is present up to 30% of the time, which makes “savolitinib and Tagrisso a potentially powerful partnership.”

At the World Congress on Lung Cancer last October, Chi-Med and AstraZeneca presented encouraging clinical evidence from proof-of-concept studies that the addition of savolitinib to Tagrisso or Iressa demonstrated preliminary anti-tumor activity in patients with epidermal growth factor receptor (EGFR) mutation-positive NSCLC with MET-amplification, who had progressed following first-line treatment with an EGFR inhibitor.

Chi-Med also is developing savolitinib for patients with papillary renal cell carcinoma (PRCC), a rare kidney cancer where c-MET is very active. In a Phase 2 study, savolitinib demonstrated clear efficacy and a durable response in PRCC patients and “we’re looking into the potential for breakthrough therapy designation here as well,” Mr. Hogg suggests. Savolitinib also was safe and well tolerated in the study.

The company is exploring development of savolitinib in more than 13 studies, with a Phase 3 trial underway in kidney cancer and another in lung cancer about to start soon.

According to Mr. Hogg, Chi-Med’s fruquintinib is likely to be the most selective inhibitor of vascular endothelial growth factor receptors (VEGFR) in clinical trials globally, providing 24-hour full target coverage. VEGFR is associated with the proliferation of blood vessels that feed cancer cells so they can grow. By shutting off their blood supply, tumor cells starve and die.

At the ASCO meeting last June, Chi-Med presented full results of the FRESCO Phase 3 study in 416 patients with locally advanced or metastatic colorectal cancer. Primary endpoint median overall survival was 9.30 months for fruquintinib, compared with 6.57 months in the control group.

“If we are able to achieve approval in this late-stage setting, we have the potential to bring fruquintinib forward into earlier treatment, where the benefits could be greater and longer,” Mr. Hogg contends. 

Fruquintinib, which is jointly developed in China with Eli Lilly, also appears to have side-stepped the hepatotoxicity exhibited by Bayer’s Stivarga, which is approved globally in third-line colorectal cancer.

In addition, fruquintinib is being studied in a Phase 3 pivotal trial in approximately 520 third-line NSCLC patients, known as the FALUCA study. Fruquintinib is concurrently being studied in a Phase 2 study in combination with Iressa in a first-line setting for patients with advanced or metastatic NSCLC. 

Last October, Chi-Med initiated the FRUTIGA Phase 3 clinical trial with fruquintinib, in combination with Taxol, in more than 500 patients with advanced gastric or gastroesophageal junction adenocarcinoma.

In the U.S., Chi-Med recently initiated a Phase 1 bridging study to evaluate the safety, tolerability and pharmacokinetics of fruquintinib in U.S. patients with advanced solid tumors. The first drug dose was administered in December.

In addition to savolitinib and fruquintinib, Mr. Hogg says Chi-Med’s third novel tyrosine kinase inhibitor, sulfatinib, has a unique angio-immuno profile and mechanism of action that inhibits the production of macrophages, which cloak cancer cells, thereby allowing the body’s immune system, specifically T-cells, a clear shot at cancer cells.

Sulfatinib is being developed against various neuroendocrine tumors (NET), which is a type of hormone cancer that is slow growing, and difficult to diagnosis and recede. Sulfatinib is progressing in multiple Phase 3 NET studies around the world.

At the 14th Annual Conference of the European Neuroendocrine Tumor Society meeting last March, Chi-Med presented Phase 1b/2 data of sulfatinib that showed objective response rates of 15% to 20% and progression free survival of 13-to-19 months.

According to Mr. Hogg, the objective response rates of current first-line treatments for NET, Sutent and Afinitor, are in the 5% to 9% range, with progression free survival of about 11 months. “We are quite excited in sulfatinib’s potential.”

Chi-Med also has high hopes for its epitinib, an epidermal growth factor receptor-mutation inhibitor, which has been designed to penetrate the blood-barrier and benefit patients with brain metastases. Phase 1b data presented at the World Congress on Lung Cancer in 2016 showed 70% response rates in NSCLC patients with measurable brain metastases, which is “very encouraging,” Mr. Hogg suggests.

Approximately 7.4% of NSCLC patients will have brain metastases at initial diagnosis and 25% to 30% will develop brain metastases during the course of their disease. Life expectancy for these patients is poor, with a median survival of only 3.4 months. “The unmet medical need is obvious,” he adds.

Chi-Med is advancing epitinib into a Chinese registration trial with NSCLC patients with brain metastases, as well as a Phase 2 study in China in glioblastoma, or primary brain cancer, both in 2018.

Mr. Hogg says China is a large and complex commercial market, with Chi-Med’s national coverage of prescription drugs and consumer health products extending to 300 cities and towns, 18,700 hospitals and 87,000 doctors.

In 2015, Chi-Med took over exclusive Chinese commercial rights of AstraZeneca’s Seroquel, a second generation antipsychotic approved for the treatment of schizophrenia, bipolar disorder and as adjunct treatment of major depressive disorder, as well as Merck Serono’s Concor in certain markets, a beta-blocker approved for the treatment of hypertension. 

Chi-Med also sells a portfolio of household prescription drugs and over-the-counter products, covering coronary artery disease, angina, anti-viral/flu, cerebrovascular disease, periodontitis and gallbladder stones, among others.

Chi-Med now has a CNS team of 120 reps to sell Seroquel, with sales of RMB253.1-million in 2016, up 29%, from 2015. Sales of Concor, which are conducted on a fee-for-service basis, reached RMB28.8-million, up 43%, from 2015.

“The next piece of our incremental growth will be approval and launch of fruquintinib in China this year,” Mr. Hogg predicts.

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