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Xenetic Biosciences (LON:XEN) said today it had taken a pivotal step in establishing the company's new drug development centre in Boston with the appointment of Dr Henry Hoppe IV.

Dr Hoppe, a biotechnology drug development executive with over 20 years' experience in recombinant protein, monoclonal antibody and stem cell expression for clinical therapies, will take become vice president of drug development.

Xenetic added that Dr Hoppe’s principal expertise lies in the processes surrounding regulatory submissions, IND filings and clinical trials, especially in the orphan and rare disease arena. 

He has written and reviewed IND/NDA CMC sections for numerous recombinant protein and gene therapy programs, including those for Cerezyme, Fabrazyme, Myozyme and Thyrogen, being four currently marketed products of the Genzyme Corporation, where he worked for 17 years.

Scott Maguire, Xenetic’s chief executive said:  "Henry's extensive drug development knowledge and experience gained during his years at Genzyme and his years as a leading consultant will be hugely valuable to Xenetic as we roll out our clinical programmes in the US and Europe."

Xenetic aims to use its new drug development centre to reduce its dependence on third party collaborators and commence clinical development in the West of its proprietary drug and vaccine pipeline.

The first two programmes to be moved into Western clinical trials will be ErepoXen, which offers an improved form of erythropoietin (EPO), and OncoHist, bio-therapeutic molecule for the treatment of tumours.

House broker Singer Capital adds that the Boston-based drug development centre will have a total of three to five staff and is primarily tasked with overseeing North America- based clinical trial. 

Last week, Dr Surender Kharbanda joined as a specialist consultant to accelerate the development of OncoHist.

Xenetic has recently explicitly broadened its focus to ‘Orphan Disease’, offering the prospect of shorter development timelines, less hefty clinical development costs, and a higher probability of successful development, the broker said. 

Importantly, the high value attributed to ‘Orphan’ candidates offers the potential of significant longer-term value to the stock. Hoppe’s skill in this area is likely to make a valuable contribution, Singer added.

The broker has a 'buy' rating and a sum-of-the–parts value for the shares of 17 pence.

Xenetic Biosciences (LON:XEN) said today it had taken a pivotal step in establishing the company's new drug development centre in Boston with the appointment of Dr Henry Hoppe IV.

Dr Hoppe, a biotechnology drug development executive with over 20 years' experience in recombinant protein, monoclonal antibody and stem cell expression for clinical therapies, will take become vice president of drug development.

Xenetic added that Dr Hoppe’s principal expertise lies in the processes surrounding regulatory submissions, IND filings and clinical trials, especially in the orphan and rare disease arena. 

He has written and reviewed IND/NDA CMC sections for numerous recombinant protein and gene therapy programs, including those for Cerezyme, Fabrazyme, Myozyme and Thyrogen, being four currently marketed products of the Genzyme Corporation, where he worked for 17 years.

Scott Maguire, Xenetic’s chief executive said:  "Henry's extensive drug development knowledge and experience gained during his years at Genzyme and his years as a leading consultant will be hugely valuable to Xenetic as we roll out our clinical programmes in the US and Europe."

Xenetic aims to use its new drug development centre to reduce its dependence on third party collaborators and commence clinical development in the West of its proprietary drug and vaccine pipeline.

The first two programmes to be moved into Western clinical trials will be ErepoXen, which offers an improved form of erythropoietin (EPO), and OncoHist, bio-therapeutic molecule for the treatment of tumours.

Xenetic Biosciences (LON:XEN) said it and its partner, the Serum Institute of India, have dosed their first intravenous patient with ErepoXen, a potential long-acting treatment for anaemia.

In total 40 chronic renal failure patients will be treated as part of the six-month phase I/IIa trial. The study is designed to confirm safety and reductions in the frequency of dosage, Xenetic said.  

EPO, or erythropoietin, is a hormone produced by the kidneys that controls the production of red blood cells. It is also used in synthetic form by physicians to treat conditions such as anaemia. 

In the case of end stage renal disease patients, EPO is administered intravenously three times a week. 

Xenetic's ErepoXen has already demonstrated in phase I and II(a) clinical trials based on the subcutaneous method of administration that it has the potential to be a long-acting version with a likely dosing profile of once per month.

Xenetic chief executive Scott Maguire said: "The commencement of our IV patient trials in India with ErepoXen is an exciting step forward in combining the two methods of EPO administration.  

“We have previously announced positive Ph IIa subcutaneous results and now, with the intravenous trial, we cover the full $9 billion market potential of EPO. 

“We now have four drug candidates under clinical development with our partners including two via our recent acquisition of SymbioTec in Germany.

“Our aim is to fund ErepoXen through to an Food & Drug Administration phase IIa at which point we will seek to out-licence this candidate."

A joint statement from the companies said: “Following a report published on Friday 20th January 2012 in The Economic Times (India), the boards of both Serum and Xenetic wish to clarify that there is absolutely no truth in the statements made in the article.”

The report quoted SIL executive director Adar C Poonawalla, the son of the founder chairman and managing director Cyrus Poonawalla, but today he said: “At no time since 2007 has Serum Institute of India contemplated selling its interest in Xenetic Biosciences and this steadfastly remains the case."

“The commitment to Xenetic will continue on a long-term basis, as Serum has already spent millions buying shares in Xenetic, set up specific facilities for manufacture of Polysialyic acid (PSA) and expended US$3.5 million on the clinical trials for PSA EPO.  Recently, Serum has subscribed to shares at 11p to reinforce its long term commitment to Xenetic.  We are also partnered with Xenetic on supplying PSA to Baxter for Factor VIII.“

Scott Maguire, chief executive of Xenetic, said:  "The commitment from Serum on these important programs was never in doubt in my mind as I have the highest regard and respect for the level of scientific and clinical development effort that Serum has made over the years and will continue to do so."

"It is, of course, distressing when the press gets it so badly wrong, and I am therefore delighted that Adar Poonawalla has been both quick and forceful in making this fulsome statement of support for Xenetic.”

Xenetic, which recently changed its name from Lipoxen, added that Serum was the sole current supplier of PSA, the polymer at the core of its PolyXen platform technology in both the ErepoXen and Baxter programmes.

Shares in Xenetic opened little changed at 8.75p.

Bio-pharma Xenetic (LON:XEN) today threatened to scrap the acquisition of German firm SymbioTec unless it receives warranties over technology promised by the vendors within the next two weeks.

Xenetic, formerly known as Lipoxen, said today that it has informed SymbioTec’s owners that if it has not received satisfactory terms by 16 January it will terminate the deal.

The £8.8 million purchase was first announced in August last year and should have completed by the end of October, but uncertainty over entitlements from future revenue streams at SymbioTec has pushed the timetable back and now threatens to scupper the whole deal.

Germany-based SymbioTec is a developer of technology that uses highly-alkaline proteins to treat a broad spectrum of cancers.

Xenetic said today it was working to achieve a commercially acceptable solution, but added,  ”A result that satisfies the company has not been achieved”.

“While the company is hopeful that a satisfactory outcome can be achieved it will maintain a robust stance on the matter and reserves all of its rights under the sale and purchase agreement,” it added.

Xenetic added that it expects to conclude an agreement with the Serum Institute of India (SIIL) by 20 January that will see the development rights of up to 14 drug candidates return to the company. 

SIIL will be issued with 9 million shares under that agreement and will also subscribe for a further 2.5m shares at 11p per share.

An open offer that was expected to raise £1.95 million following the completion of the SymbioTec acquisition is on hold until a final decision on the deal is made and will also depend on market conditions at the time, Xenetic said.

Biopharmaceutical firm Xenetic Biosciences (LON:XEN) reported this morning that it had completed the subscription agreement it arranged in August to raise £12.2 million.

Xenetic deal’s with SynBio – a Russian drug development company – was to raise £12.2 million in exchange for 110.8 million shares in Xenetic at 11 pence each (which represents a premium of 69.2 per cent to Xenetic’s closing price yesterday).

The firm also revealed in August that it would be buying German firm SymbioTec – a developer of technology that uses highly-alkaline proteins to treat a broad spectrum of cancers. Today, it said that it expects the completion of this acquisition will occur no later than December 15.

“The company now has the capital to accelerate its drug development pipeline and, in our view, significantly enhance shareholder value,” said M. Scott Maguire, Xenetic’s chief executive officer. “Our primary focus will be on the positive human clinical data that is being generated by our partnerships in Russia and India, thereby providing comfort on the drug candidates' potential for success.”

Maguire added that the firm’s de-risked approach to biotech development “is exemplified through the 12 novel drug candidates under the Russian and Indian human proof of concept initiatives” and that this, combined with the potentially large number of additional new candidates that can be developed using the firm’s platform technologies, “is expected to yield significant shareholder value going forward”.

In August Xenetic struck a deal with SynBio – a Russian drug development company – to raise £12.2 million in exchange for 110.8 milion shares in Xenetic at 11 pence each. It also revealed that it would be buying German firm SymbioTec – a developer of technology that uses highly-alkaline proteins to treat a broad spectrum of cancers.

The transfer of 34 million Xenetic shares to SynBio is a transfer that must be appropriately registered with the relevant authorities in the Russian Federation, the firm said. After completion of the registration process, Rusnano will inject cash funding into SynBio that will enable it to complete its subscription agreement with Xenetic by subscribing for the 110.8 million Xenetic shares.

The target date for the completion of the subscription agreement is now expected to be November 25. However, the firm stressed that achieving this date is dependent on the speed with which the registration process can be effect in Russia.

The acquisition of SymbioTec is intended to occur around the same date, but Xenetic said it had made provision so that it could occur by December 15 at the latest.

“The transactions involved in what is a complex set of deals spell a new beginning for the company as they enable us to implement our strategy of de-risking biotech,” said Scott Maguire, Xenetic’s chief executive officer. “With the new co-development Agreement with SynBio, we will have 12 drug candidates in various stages of development in Russia and India via licenses. The data generated by our partners will give human proof of concept on the drug candidates' merits as a therapy, thus taking a large element of the risk out of drug development and allowing us to decide which drug candidates have a good chance of success before we allocate our newly acquired cash resources to US and European clinical trials.”

Biopharmaceuticals firm Xenetic Biosciences (LON:XEN) said it is continuing to work with partners to close a number of transactions announced last month that are designed to transform the company.

In August Xenetic struck a deal with SynBio – a Russian drug development company – to raise £12.2 million in exchange for 110.8 milion shares in Xenetic at 11 pence each. It also revealed that it would be buying German firm SymbioTec – a developer of technology that uses highly-alkaline proteins to treat a broad spectrum of cancers.

These transactions were due to be closed by September 30, but Xenetic said today that, although it and its Russian and German partners have fulfilled their respective contractual obligations,  process delays have occurred in both Russia and Germany such that closing by today is now not possible. The firm added that the closing of the transactions is now expected to take place during the second half of October.

“In spite of there being a modest delay in this matter, the transactions represent a pivotal deal for the company – to say nothing of their importance to the Russian State in developing their global biotech industry,” said M. Scott Maguire, Xenetic’s chief executive officer. “Consequently all parties will continue to work assiduously to achieve closing as soon as practically possible.”

Biopharmaceuticals firm Xenetic Biosciences (LON:XEN) said that it will next week take part in a Russia-UK trade event in Moscow timed to coincide with Prime Minister David Cameron’s official visit to Russia.

Xenetic said the Russia-UK VIP Roundtable, which has been organised by the London Stock Exchange, will include “key players” in UK and Russian capital markets such as: Xavier Rolet, the LSE’s chief executive officer; Dmitry Pankin, head of Russia’s Federal Financial Markets Service; Nick Baird, UK Trade & Investment’s CEO; and Ruben Aganbegyan, MICEX Group’s CEO. Scott Maguire, CEO of Xenetic, will be representing the company at the event.

Xenetic, which specialises in the development of high-value differentiated biologic drugs and vaccines, last month struck a deal to with SynBio – a new Russian drug development company. The Russian state-sponsored nanotechnology fund, Rusnano, is investing around US$45 into SynBio, which is to enter into a co-development agreement with Xenetic for the development of up to drug products using the firm’s patented platform drug technologies.

With this co-development agreement in place, Xenetic now has 12 products in various stages of development in Russia. These products cover a range of markets, from potential blockbuster therapies for the likes of diabetes and anaemia to orphan drug markets like cystic fibrosis and acute myeloid leukaemia.

Biopharmaceutical firm Xenetic Biosciences (LON:XEN) has been told a patent application covering its co-delivery technology in the US can go ahead. The firm added that it will provide an update once its patent has been granted.

The firm also confirmed today its change of name to Xenetic from Lipoxen following shareholder approval at its general meeting at the start of this month. In early August, Lipoxen revealed that it would be buying German cancer drug firm SymbioTech in an £8.8 million deal designed to transform the company.

Xenetic, which specialises in the development of high-value differentiated biologic drugs and vaccines, said that its co-delivery patent deals with a unique method of genetic immunisation. The method involves packaging a protein vaccine together with a plasmid DNA that encodes the vaccine, in the same liposome and regardless of the liposome size. This, said Xenetic, ensures that both the protein vaccine and the DNA encoding the vaccine are delivered simultaneously (called “co-delivery”) in the same antigen-presenting cells.

The patent provides protection for the co-delivery technology that is used in the company’s ImuXen product range, it said. Xenetic Biosciences’ ImuXen liposomal technology platform can be used to create and deliver DNA, protein-based, vaccines capable of generating enhanced immune responses.

The firm added that it already has patents granted in relation to this technology in Europe, Russia and China.

Biopharmaceuticals firm Lipoxen (LON:LPX) announced this morning that it had reduced its losses during the first six months of this year but that the results should be seen in the context of recent deals designed to transform the company. The firm also announced it is to change its name to Xenetic Biosciences.

Lipoxen said its loss before tax reduced to £1.3 million (H1 2010: £1.5 million) on turnover that of £64,000 (H1 2010: £76,000)

Earlier this month Lipoxen revealed that it would be buying German firm SymbioTec – a developer of technology that uses highly-alkaline proteins to treat a broad spectrum of cancers. The acquisition, using Lipoxen paper, valued SymbioTech at £8.8 million.

Lipoxen also struck a deal this month to bring on board a strategic investor in the shape of Russian state-owned nanotechnology investor SynBio. SynBio is acquiring 110.8 million shares at 11 pence each, raising £12.2 million for the company.

“We are pleased that in the current market environment we have secured the Company's capital needs for at least two years and further delighted that the Placing will be conducted at a substantial premium,” said M. Scott Maguire, Lipoxen’s chief executive officer.

Magure also said that the board is confident that proposals being presented to shareholders transform the company, reducing its dependence on third parties, allowing it to control its destiny through proprietary drug development, the acquisition of complementary natural platform technologies and new orphan drug candidates with near-term commercialisation potential. 

“Given the transformational nature of the proposals, the board has determined that a change in the company's name is appropriate. Xenetic Biosciences will allow greater strategic flexibility by lessening the focus on liposomes, our secondary platform technology,” he added.

After opening up sharply today, Lipoxen’s shares fell back and were trading 0.5 per cent higher at 7.66 pence each by 8:47am.

The report called Lipoxen a different company from its peers as instead of relying on one or two very early stage drug candidates or securing a clinical trial partner before running out of cash, it operates a low risk clinical development strategy.

“Nevertheless, we have adopted a cautious approach to prospective revenue generation in our model that extends out to 2021, and after applying very demanding discount rates indicates an initial target price of 30.7p per share,” said GE&CR.

The projections see Lipoxen’s sales climbing from £469,000 in 2010 to £4.2 million in 2014, when the company would make a pre-tax profit of £650,000 and post earnings per share of 0.43 pence.

The research firm added that Lipoxen's technology is generating an increasing number of candidates in therapeutic areas of high unmet need.